Trial Outcomes & Findings for 36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds (NCT NCT00728260)
NCT ID: NCT00728260
Last Updated: 2015-02-12
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 comparison window. Clinical setting is given in parenthesis as (H) for hospital.
Recruitment status
COMPLETED
Target enrollment
1421 participants
Primary outcome timeframe
Day 0 up to Day 30 post-vaccination
Results posted on
2015-02-12
Participant Flow
Study participant accrual occurred from 18 October 2007 through 17 October 2010. Kaiser Permanente databases were reviewed for this study.
Medical utilization databases were reviewed for children 2 through 10 years of age receiving Menactra vaccine within Kaiser Permanente to identify the following medical care events during the 6 months after Menactra vaccination: all outcomes from hospitalizations and emergency department visits and selected outcomes from clinic visits.
Participant milestones
| Measure |
Menactra Vaccine Recipients
Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
1421
|
|
Overall Study
COMPLETED
|
1421
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
Baseline characteristics by cohort
| Measure |
Menactra Vaccine Recipients
n=1421 Participants
Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice.
|
|---|---|
|
Age, Categorical
<=18 years
|
1421 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.36 Years
STANDARD_DEVIATION 2.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
709 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
712 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1421 participants
n=5 Participants
|
|
Seasonality
December - February
|
163 Participants
n=5 Participants
|
|
Seasonality
March - May
|
372 Participants
n=5 Participants
|
|
Seasonality
June - August
|
593 Participants
n=5 Participants
|
|
Seasonality
September - November
|
294 Participants
n=5 Participants
|
|
Indication for Vaccination
Asplenia (Surgical or Congenital)
|
17 Participants
n=5 Participants
|
|
Indication for Vaccination
Complement Deficiency
|
2 Participants
n=5 Participants
|
|
Indication for Vaccination
Hereditary Elliptocytosis
|
1 Participants
n=5 Participants
|
|
Indication for Vaccination
Hereditary Spherocytosis
|
8 Participants
n=5 Participants
|
|
Indication for Vaccination
Sickle Cell Disease
|
44 Participants
n=5 Participants
|
|
Indication for Vaccination
Thalassemias
|
22 Participants
n=5 Participants
|
|
Indication for Vaccination
Other Hemoglobinopathy
|
9 Participants
n=5 Participants
|
|
Indication for Vaccination
Human Immunodeficiency Virus Infection
|
1 Participants
n=5 Participants
|
|
Indication for Vaccination
Travel-Related
|
364 Participants
n=5 Participants
|
|
Indication for Vaccination
Not Available
|
987 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 30 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 comparison window. Clinical setting is given in parenthesis as (H) for hospital.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=1421 Participants
Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice.
|
|---|---|
|
Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Cellulitis and abscess (All ages combined; H)
|
1.4 Events per 1,000 person-months
|
|
Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Cellulitis and abscess (Subj.10 Yrs Old; H; n=870)
|
2.3 Events per 1,000 person-months
|
PRIMARY outcome
Timeframe: Day 31 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 each comparison window. Clinical setting is given in parenthesis as (H) for hospital.
Outcome measures
| Measure |
Menactra Vaccine Recipients
n=1421 Participants
Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice.
|
|---|---|
|
Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Cellulitis and abscess (All ages combined; H)
|
0.0 Events per 1,000 person-months
|
|
Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Cellulitis and abscess (Subj.10 Yrs Old; H; n=870)
|
0.0 Events per 1,000 person-months
|
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=1421 Participants
Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice.
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|---|---|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Abdominal pain
|
0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Aspergillosis
|
0.70 Events per 1,000 doses
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Asthma
|
0.70 Events per 1,000 doses
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Cellulitis and abscess
|
1.41 Events per 1,000 doses
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Cerebral palsy
|
0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Congenital anomaly of ureter
|
0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Congenital atresia
|
0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Digestive congenital anomalies
|
070 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Febrile illness
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2.81 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Feeding problem
|
0.70 Events per 1,000 doses
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Hereditary spherocytosis
|
0.70 Events per 1,000 doses
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Hydronephrosis
|
0.70 Events per 1,000 doses
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Malignant neoplasm
|
5.63 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Other non-traumatic joint disorders
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0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Pneumonia
|
0.70 Events per 1,000 doses
|
|
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Psychiatric
|
0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Pyogenic arthritis
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0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Respiratory infection, upper
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0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Sickle cell anemia
|
5.63 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Small bowel obstruction
|
0.70 Events per 1,000 doses
|
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Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
Trauma
|
2.11 Events per 1,000 doses
|
Adverse Events
Menactra Vaccine Recipients
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menactra Vaccine Recipients
n=1421 participants at risk
Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice.
|
|---|---|
|
Congenital, familial and genetic disorders
Congenital Anomaly of ureter
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Congenital, familial and genetic disorders
Sickle Cell Anemia
|
0.56%
8/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Gastrointestinal disorders
Abdominal Pain
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0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
General disorders
Febrile Illness
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0.28%
4/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Metabolism and nutrition disorders
Feeding problem
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0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Infections and infestations
Aspergillosis
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Infections and infestations
Pyogenic arthritis
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Infections and infestations
Respiratory infection, upper
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Injury, poisoning and procedural complications
Trauma
|
0.21%
3/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Psychiatric disorders
Psychiatric
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Congenital, familial and genetic disorders
Digestive congenital anomalies
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Congenital, familial and genetic disorders
Congenital atresia
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Congenital, familial and genetic disorders
Cerebral palsy
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Infections and infestations
Cellulitis and abscess
|
0.14%
2/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Congenital, familial and genetic disorders
Hereditary spherocytosis
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm
|
0.56%
8/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Musculoskeletal and connective tissue disorders
Other non-traumatic joint disorders
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1421 • Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient 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