Trial Outcomes & Findings for Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine (NCT NCT00254995)
NCT ID: NCT00254995
Last Updated: 2016-04-19
Results Overview
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Recruitment status
COMPLETED
Target enrollment
62626 participants
Primary outcome timeframe
Day 0 up to Day 60 post-vaccination
Results posted on
2016-04-19
Participant Flow
Study participant accrual occurred from 15 July 2005 through 14 April 2006.
Databases were reviewed to identify persons who received Menactra vaccine within Kaiser Permanente and to identify all medical care events for the 6-month period following vaccination or, if applicable, through the end of pregnancy. Subjects served as their own control for 0-30 days surveillance, age-matched control served for the 6-month period.
Participant milestones
| Measure |
Menactra Vaccine Recipients
Kaiser Permanente members who received Menactra vaccine during the study period.
Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice.
|
Control Group
Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.
Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice.
|
|---|---|---|
|
Overall Study
STARTED
|
31561
|
31065
|
|
Overall Study
COMPLETED
|
31561
|
31065
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
Baseline characteristics by cohort
| Measure |
Menactra Vaccine Recipients
n=31561 Participants
Kaiser Permanente members who received Menactra vaccine during the study period.
Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study.
|
Control Group
n=31065 Participants
Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.
Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study.
|
Total
n=62626 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.6 Years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
15.65 Years
STANDARD_DEVIATION 5.56 • n=7 Participants
|
15.6 Years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
26805 Participants
n=5 Participants
|
26383 Participants
n=7 Participants
|
53188 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4732 Participants
n=5 Participants
|
4658 Participants
n=7 Participants
|
9390 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Gender
Female
|
15722 Participants
n=5 Participants
|
15369 Participants
n=7 Participants
|
31091 Participants
n=5 Participants
|
|
Gender
Male
|
15836 Participants
n=5 Participants
|
15696 Participants
n=7 Participants
|
31532 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31561 participants
n=5 Participants
|
31065 participants
n=7 Participants
|
62626 participants
n=5 Participants
|
|
Seasonality
December - February
|
4689 Participants
n=5 Participants
|
4671 Participants
n=7 Participants
|
9360 Participants
n=5 Participants
|
|
Seasonality
March - May
|
3605 Participants
n=5 Participants
|
3602 Participants
n=7 Participants
|
7207 Participants
n=5 Participants
|
|
Seasonality
June - August
|
17577 Participants
n=5 Participants
|
17080 Participants
n=7 Participants
|
34657 Participants
n=5 Participants
|
|
Seasonality
September - November
|
5739 Participants
n=5 Participants
|
5712 Participants
n=7 Participants
|
11451 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 60 post-vaccinationPopulation: All persons who received Menactra vaccine during the study period were included in the analysis.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=31561 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
n=31065 Participants
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
Abdominal pain (ER)
|
0.98 Events per 1,000 person-months
|
0.52 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
Febrile illness (ER)
|
0.38 Events per 1,000 person-months
|
0.03 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
Suicidal Ideation/Attempt (ER)
|
0.19 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 180 post-vaccinationPopulation: All persons who received Menactra vaccine during the study period were included in the analysis.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=31561 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
n=31065 Participants
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Vomiting (ER)
|
0.21 Events per 1,000 person-months
|
0.11 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Elective procedure (H)
|
0.19 Events per 1,000 person-months
|
0.09 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Febrile illness (ER)
|
0.25 Events per 1,000 person-months
|
0.13 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Genital pain (ER)
|
0.03 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Hyperglycemia (ER)
|
0.03 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Mononucleosis (ER)
|
0.03 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Tympanic perforation (H)
|
0.03 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 60 post-vaccinationPopulation: All persons who received Menactra vaccine during the study period were included in the analysis.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=21407 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
n=21407 Participants
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance
Adominal pain (age 11-16 years; ER)
|
1.07 Events per 1,000 person-months
|
0.38 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance
Febrile illness (age 11-16 years; ER)
|
0.33 Events per 1,000 person-months
|
0.05 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance
Suicidal Ideation/Attempt (age 11-16 years; ER)
|
0.23 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 180 post-vaccinationPopulation: All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=21407 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
n=21407 Participants
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Diabetes Type 1 (Prior onset)[age 11-16 years; ER]
|
0.04 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Difficulty breathing/SOB (age 11-16 years; ER)
|
0.07 Events per 1,000 person-months
|
0.02 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Elective procedure (age 11-16 years; H)
|
0.20 Events per 1,000 person-months
|
0.06 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Febrile illness (age 11-16 years; ER)
|
0.23 Events per 1,000 person-months
|
0.12 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Hives/Urticaria (age 11-16 years; C)
|
0.40 Events per 1,000 person-months
|
0.24 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Mononucleosis (age 17-18 years; ER)
|
0.10 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Otitis Externa (age 11-16 years; ER)
|
0.04 Events per 1,000 person-months
|
0.00 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Vomiting (age 11-16 years; ER)
|
0.18 Events per 1,000 person-months
|
0.09 Events per 1,000 person-months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 180 post-vaccinationPopulation: All persons who received Menactra vaccine during the study period were included in the analysis.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=31561 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
n=31065 Participants
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Abscess/Cellulitis (ER)
|
0.12 Events per 1,000 person-months
|
0.25 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Allergic reaction (ER)
|
0.01 Events per 1,000 person-months
|
0.06 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Allergy, drug (ER)
|
0.00 Events per 1,000 person-months
|
0.03 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Benign lesion (H)
|
0.12 Events per 1,000 person-months
|
0.24 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Congenital anomaly (H)
|
0.10 Events per 1,000 person-months
|
0.18 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Cyst (H)
|
0.04 Events per 1,000 person-months
|
0.10 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Fatigue (ER)
|
0.01 Events per 1,000 person-months
|
0.04 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Insect bite (ER)
|
0.01 Events per 1,000 person-months
|
0.05 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Musculoskeletal pain (ER)
|
0.27 Events per 1,000 person-months
|
0.39 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Pelvic pain (ER)
|
0.01 Events per 1,000 person-months
|
0.08 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Poisoning/Ingestion (H)
|
0.02 Events per 1,000 person-months
|
0.07 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Post-operative complication (ER)
|
0.01 Events per 1,000 person-months
|
0.07 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Post-operative complication (H)
|
0.01 Events per 1,000 person-months
|
0.04 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Pregnancy delivery (H)
|
0.00 Events per 1,000 person-months
|
0.03 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Psychiatric (ER)
|
0.44 Events per 1,000 person-months
|
0.70 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Psychiatric (H)
|
0.33 Events per 1,000 person-months
|
0.58 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Testicular pain (ER)
|
0.01 Events per 1,000 person-months
|
0.05 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Tonsillitis (H)
|
0.09 Events per 1,000 person-months
|
0.28 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Trauma (ER)
|
3.77 Events per 1,000 person-months
|
5.13 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Vision disorder (H)
|
0.01 Events per 1,000 person-months
|
0.05 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
Well care/Reassurance/Follow-up (ER)
|
0.07 Events per 1,000 person-months
|
0.24 Events per 1,000 person-months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 180 post-vaccinationPopulation: All persons who received Menactra vaccine during the study period were included in the analysis.
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=31392 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
n=31065 Participants
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Abdominal pain (age 30-55 years; ER)
|
0.21 Events per 1,000 person-months
|
1.89 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Abscess/Cellulitis (age 11-16 years; ER)
|
0.06 Events per 1,000 person-months
|
0.13 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Allergic reaction (age 11-16 years; ER)
|
0.00 Events per 1,000 person-months
|
0.04 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Benign lesion (age 11-16 years; H)
|
0.09 Events per 1,000 person-months
|
0.22 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Congenital anomaly (age 11-16 years; H)
|
0.09 Events per 1,000 person-months
|
0.21 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Cyst (age 11-16 years; H)
|
0.03 Events per 1,000 person-months
|
0.09 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Pelvic pain (age 17-18 years; ER)
|
0.00 Events per 1,000 person-months
|
0.17 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Post-operative complication (age 17-18 years; ER)
|
0.02 Events per 1,000 person-months
|
0.15 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Psychiatric (age 11-16 years; H)
|
0.32 Events per 1,000 person-months
|
0.52 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Psychiatric (age 17-18 years; ER)
|
0.43 Events per 1,000 person-months
|
1.34 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Psychiatric (age 17-18 years; H)
|
0.38 Events per 1,000 person-months
|
0.77 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Testicular pain (age 11-16 years; ER)
|
0.01 Events per 1,000 person-months
|
0.06 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Tonsillitis (age 11-16 years; H)
|
0.09 Events per 1,000 person-months
|
0.26 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Tonsillitis (age 17-18 years; ER)
|
0.04 Events per 1,000 person-months
|
0.22 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Tonsillitis (age 17-18 years; H)
|
0.10 Events per 1,000 person-months
|
0.39 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Trauma (age 11-16 years; ER)
|
3.88 Events per 1,000 person-months
|
4.66 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Trauma (age 17-18 years; ER)
|
3.62 Events per 1,000 person-months
|
5.27 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Trauma (age 19-29 years; ER)
|
3.53 Events per 1,000 person-months
|
10.9 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Trauma (age 19-29 years; H)
|
0.00 Events per 1,000 person-months
|
1.28 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Trauma (age 30-55 years; ER)
|
2.52 Events per 1,000 person-months
|
9.41 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Trauma (age 30-55 years; H)
|
0.00 Events per 1,000 person-months
|
1.05 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Well care/Reassurance/Follow-up (age 11-16 yrs;ER)
|
0.05 Events per 1,000 person-months
|
0.17 Events per 1,000 person-months
|
|
Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
Well care/Reassurance/Follow-up (age 17-18 yrs;ER)
|
0.10 Events per 1,000 person-months
|
0.37 Events per 1,000 person-months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to 6 months post-vaccinationPopulation: Only all persons who received Menactra vaccine during the study period were included in the analysis.
Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=31561 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined.
Cardiac arrest
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined.
Pregnancy
|
0.03 Events per 1,000 doses
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to 6 months post-vaccinationPopulation: Only persons who received Menactra vaccine during the study period were included in the analysis.
Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=31561 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Abdominal pain
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Abscess/Cellulitis
|
0.38 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Acute renal failure
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Appendicitis
|
0.57 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Arrhythmia
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Aseptic meningitis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Asphyxiation
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Asthma/Reactive airway disease
|
0.16 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Benign lesion
|
0.16 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
COPD
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cancer, Cervix
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cancer, Melanoma
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cancer, Ovarian
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cancer, Pancreatic
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cancer, Rule out cancer
|
0.16 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cholelithiasis
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Chronic inflammatory demyelinating polyneuritis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Complications of transplanted organ
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Congenital anomaly
|
0.38 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Congenital heart disease
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Constipation
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cranial nerve palsy
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Cyst
|
0.13 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Dehydration
|
0.10 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Delirium tremens
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Dental
|
0.10 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Diabetes type I (Diagnosed after vaccination)
|
0.10 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Diabetes type I (Diagnosed before vaccination)
|
0.13 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Diarrhea
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Elective procedure
|
0.22 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Encephalitis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Encephalitis due to Epstein-Barr virus
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
End-stage renal disease
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Epilepsy (Hx of seizure disorder possible seizure)
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Epilepsy (Seizure event, w/hx of seizure disorder)
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Fatty liver
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Febrile illness
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Femoral epiphysiolysis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Foreign body
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Gastroesophageal reflux
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Gastroenteritis
|
0.19 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Hodgkin's disease
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Horner's syndrome
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Hydrocephalus
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Hypertension
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
ITP (Diagnosed before vaccination)
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Idiopathic polycystic splenomegaly
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Inguinal hernia/repair
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Kyphosis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Labyrinthitis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Lymphocytic leukemia (Chronic, diagnosed before)
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Migraine
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Osteomyelitis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pancreatitis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pectus excavatum
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pelvic inflammatory disease
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pharyngitis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pneumocystosis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pneumonia
|
0.13 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pneumothorax
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Poisoning/ingestion
|
0.06 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pregnancy
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Pregnancy - Stillborn delivery post prolapsed cord
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Psychiatric
|
1.93 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Plumonary embolism
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Respiratory syncytial virus infection
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Renal calculus
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Scoliosis
|
0.19 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Sickle cell disease
|
0.10 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Sleep apnea
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Splenomegaly
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Suicidal ideation/attempt
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Syncope/Loss of consciousness
|
0.10 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
SLE (Diagnosed after vaccination; symptoms before)
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
SLE (Diagnosed before vaccination)
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Temporomandibular joint disorder
|
0.19 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Testicular torsion
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Thrombocytopenia (Chronic, diagnosed before vacc.)
|
0.10 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Tonsillitis
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Toxic shock syndrome
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Transplant rejection
|
0.03 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Trauma
|
1.20 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Urinary tract infection
|
0.10 Events per 1,000 doses
|
—
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Viral syndrome
|
0.03 Events per 1,000 doses
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Determination of Pregnancy OutcomePopulation: Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded.
Only persons who received Menactra vaccine during the study period were included in this outcome.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=31561 Participants
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
Control Group
The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
|
|---|---|---|
|
Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination
Live births
|
11 Paticipants
|
—
|
|
Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination
Live births with congenital anomaly (facial cyst)
|
1 Paticipants
|
—
|
|
Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination
Elective abortion
|
5 Paticipants
|
—
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Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination
Early fetal death
|
1 Paticipants
|
—
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Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination
Lost to follow up
|
7 Paticipants
|
—
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Adverse Events
Menactra Vaccine Recipients
Serious events: 273 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menactra Vaccine Recipients
n=31558 participants at risk；n=31561 participants at risk
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia (Chronic, Precedes)
|
0.01%
3/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura (Precedes)
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Congenital, familial and genetic disorders
Congenital Anomaly
|
0.04%
12/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Congenital, familial and genetic disorders
Congenital Heart Disease
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Congenital, familial and genetic disorders
Sickle Cell Disease
|
0.01%
3/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Congenital, familial and genetic disorders
Pectus Excavatum
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Gastrointestinal disorders
Constipation
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
General disorders
Cyst
|
0.01%
4/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.01%
3/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
General disorders
Febrile Illness
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Psychiatric disorders
Delirium Tremens
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Hepatobiliary disorders
Fatty Liver
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Immune system disorders
Transplant Rejection
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Abscess/Cellulitis
|
0.04%
12/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Appendicitis
|
0.06%
18/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Gastroenteritis
|
0.02%
6/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Pneumonia
|
0.01%
4/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Urinary tract infection
|
0.01%
3/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Aseptic Meningitis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Encephalitis due to Epstein-Barr Virus
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Viral Syndrome
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Pharyngitis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Tonsillitis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Toxic Shock Syndrome
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Injury, poisoning and procedural complications
Complications of Transplanted Organ
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Injury, poisoning and procedural complications
Poisoning/Ingestion
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Injury, poisoning and procedural complications
Trauma
|
0.12%
38/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Metabolism and nutrition disorders
Diabetes, Type 1 (New Onset)
|
0.01%
3/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Metabolism and nutrition disorders
Diabetes, Type 1 (Prior Onset)
|
0.01%
4/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Musculoskeletal and connective tissue disorders
Femoral Epiphysiolysis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus (New dx, symptoms precede)
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus (Prior onset)
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.02%
6/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular Joint Disorder
|
0.02%
6/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, Cervix
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, Melanoma
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, Ovarian
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, Pancreatic
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lesion NOS
|
0.02%
5/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, R/O Cancer
|
0.02%
5/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's Disease
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic Leukemia (Chronic, Precedes)
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Encephalitis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Cranial Nerve Palsy
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Chronic Inflammatory Demyelinating Polyneuritis (Prior onset)
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Epilepsy (Hx of Seizure Disorder, possible seizure)
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Epilepsy (Seizure Event, w/hx of Seizure Disorder)
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Horner's Syndrome
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Migraine
|
0.01%
2/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Nervous system disorders
Syncope/LOC
|
0.01%
3/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Reproductive system and breast disorders
Pregnancy
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Reproductive system and breast disorders
Pregnancy - Stillborn Delivery post Prolapsed Cord
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Psychiatric disorders
Psychiatric
|
0.19%
61/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Psychiatric disorders
Suicidal Ideation/Attempt
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Renal and urinary disorders
Renal Calculus
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Renal and urinary disorders
End-Stage Renal Disease
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma/RAD
|
0.02%
5/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxiation
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Surgical and medical procedures
Elective Procedure
|
0.02%
7/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Surgical and medical procedures
Inguinal Hernia/Repair
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Gastrointestinal disorders
Tooth disorder (Dental)
|
0.01%
3/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Vascular disorders
Hypertension
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Idiopathic Polycystic Splenomegaly
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
|
Infections and infestations
Pneumocystosis
|
0.00%
1/31561 • Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER