Trial Outcomes & Findings for Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060) (NCT NCT00440297)
NCT ID: NCT00440297
Last Updated: 2017-04-13
Results Overview
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
277 participants
Primary outcome timeframe
7 months (1 month after the third dose)
Results posted on
2017-04-13
Participant Flow
22-Dec-2006 (First Patient Enrolled in Study) to 05-May-2008 (Last Participant had their Last Visit). This study was conducted at 23 sites: 7 in Canada, 8 in the United Kingdom, 5 in Italy, and 3 in Spain. In the Modified Process group, one participant was randomized by mistake, and therefore was not vaccinated.
A screening serum sample was obtained prior to study entry and assayed for hepatitis B serologic markers. Only patients that were seronegative were considered for enrollment.
Participant milestones
| Measure |
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
138
|
|
Overall Study
Vaccination Visit 1
|
138
|
138
|
|
Overall Study
Vaccination Visit 2
|
136
|
134
|
|
Overall Study
Vaccination Visit 3
|
124
|
125
|
|
Overall Study
Vaccination Visit 4
|
116
|
122
|
|
Overall Study
COMPLETED
|
116
|
120
|
|
Overall Study
NOT COMPLETED
|
23
|
18
|
Reasons for withdrawal
| Measure |
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
11
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
|
Overall Study
Randomized by mistake
|
1
|
0
|
Baseline Characteristics
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Baseline characteristics by cohort
| Measure |
Modified Process Hepatitis B Vaccine
n=138 Participants
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
n=138 Participants
ENGERIX-B™, 2 x 20 µg(micrograms)
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
69.2 Years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
69.5 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 months (1 month after the third dose)Population: Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose).
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=101 Participants
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
n=111 Participants
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7
|
49 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: 9 months (1 month after the fourth dose)Population: Per-Protocol Population: The Per- Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose).
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=99 Participants
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
n=104 Participants
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9
|
66 Participants
|
72 Participants
|
PRIMARY outcome
Timeframe: Days 1-15 After Any VaccinationPopulation: Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=138 Participants
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
n=135 Participants
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
The Total Number of Participants With One or More Injection-Site Adverse Experiences
|
43 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Days 1-5 After Any VaccinationPopulation: Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=138 Participants
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
n=135 Participants
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 0-9 months (recorded from first dose until the participant completes or discontinues the study)Population: Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up
Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=138 Participants
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
n=135 Participants
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
|
0 Participants
|
0 Participants
|
Adverse Events
Modified Process Hepatitis B Vaccine
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
ENGERIX-B™
Serious events: 11 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Cardiac disorders
Myocardial Infarction
|
2.9%
4/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Renal and urinary disorders
Renal failure
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Liver function test abnormal
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
Other adverse events
| Measure |
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
|
ENGERIX-B™
ENGERIX-B™, 2 x 20 µg(micrograms)
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
5/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
4.4%
6/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
2.2%
3/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Asthenia
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Fatigue
|
2.9%
4/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Edema peripheral
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
2.2%
3/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Pyrexia
|
2.9%
4/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
4.4%
6/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Infections and infestations
Cystitis
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
2.2%
3/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
2.2%
3/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
2.2%
3/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
3.0%
4/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.74%
1/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Nervous system disorders
Dizziness
|
2.9%
4/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
3.7%
5/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Nervous system disorders
Headache
|
5.8%
8/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
5.9%
8/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
3.0%
4/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.4%
2/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
0.00%
0/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Injection site Erythema
|
5.1%
7/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
14.1%
19/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Injection site Edema
|
0.72%
1/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
1.5%
2/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Injection site Pain
|
23.2%
32/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
28.9%
39/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
|
General disorders
Injection site Swelling
|
8.7%
12/138 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
10.4%
14/135 • All adverse events: Days 1-15 after any vaccination; Deaths and vaccine-related serious adverse events: up to 9 months
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER