Trial Outcomes & Findings for Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED) (NCT NCT00440531)
NCT ID: NCT00440531
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 vaccination) and at Month 7 (1 month after the third vaccination).
COMPLETED
PHASE3
540 participants
7 months (1 month after third vaccination)
2017-04-13
Participant Flow
27-Nov-2006 (First Participant Enrolled in Study) to 26-Nov-2007 (Last Participant had their Last Visit). This study was conducted at 22 sites: 10 in Canada, 2 in Denmark, 5 in Sweden, and 5 in the United Kingdom.
In the Modified Process group, 2 participants were randomized but not vaccinated: 1 participant withdrew consent, and 1 participant had an SAE (Serious Adverse Experience) of hypertension prior to vaccination.
Participant milestones
| Measure |
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
ENGERIX-B™, 20 µg (micrograms)
|
|---|---|---|---|
|
Overall Study
STARTED
|
185
|
183
|
172
|
|
Overall Study
Vaccination 1
|
183
|
183
|
172
|
|
Overall Study
Vaccination 2
|
181
|
182
|
171
|
|
Overall Study
Vaccination 3
|
176
|
178
|
166
|
|
Overall Study
COMPLETED
|
175
|
178
|
165
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
7
|
Reasons for withdrawal
| Measure |
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
ENGERIX-B™, 20 µg (micrograms)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
5
|
|
Overall Study
see pre-assignment details
|
2
|
0
|
0
|
Baseline Characteristics
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Modified Process Hepatitis B Vaccine
n=183 Participants
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
n=183 Participants
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
n=172 Participants
ENGERIX-B™, 20 µg (micrograms)
|
Total
n=538 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
278 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 months (1 month after third vaccination)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 vaccination) and at Month 7 (1 month after the third vaccination).
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=152 Participants
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
n=147 Participants
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
ENGERIX-B™, 20 µg (micrograms)
|
|---|---|---|---|
|
The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
|
115 Participants
|
100 Participants
|
—
|
SECONDARY outcome
Timeframe: 7 months (1 month after third vaccination)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 vaccination) and at Month 7 (1 month after the third vaccination).
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=144 Participants
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
ENGERIX-B™, 20 µg (micrograms)
|
|---|---|---|---|
|
The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)
|
121 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-5 After Any VaccinationPopulation: Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=182 Participants
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
n=183 Participants
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
n=171 Participants
ENGERIX-B™, 20 µg (micrograms)
|
|---|---|---|---|
|
The Total Number of Participants With One or More Injection-site Adverse Experiences
|
103 Participants
|
115 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: Day 1-5 After VaccinationPopulation: Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=182 Participants
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
n=183 Participants
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
n=171 Participants
ENGERIX-B™, 20 µg (micrograms)
|
|---|---|---|---|
|
The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)Population: Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine
n=182 Participants
Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
|
RECOMBIVAX-HB™
n=183 Participants
RECOMBIVAX-HB™, 10 µg (micrograms)
|
ENGERIX-B™
n=171 Participants
ENGERIX-B™, 20 µg (micrograms)
|
|---|---|---|---|
|
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Clinical and Quantitative Sciences
Merck Sharp & Dohme Corp
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