Trial Outcomes & Findings for The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines (NCT NCT01203319)
NCT ID: NCT01203319
Last Updated: 2012-04-27
Results Overview
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1091 participants
Primary outcome timeframe
one month after the second vaccination
Results posted on
2012-04-27
Participant Flow
Participant milestones
| Measure |
60mcg/1.0ml Recombinant Hepatitis B Vaccine
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
30mcg/1.0ml Recombinant Hepatitis B Vaccine
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
10mcg/1.0ml Recombinant Hepatitis B Vaccine
300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
|---|---|---|---|
|
Overall Study
STARTED
|
434
|
435
|
222
|
|
Overall Study
COMPLETED
|
428
|
426
|
217
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines
Baseline characteristics by cohort
| Measure |
60mcg/1.0ml Recombinant Hepatitis B Vaccine
n=434 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
30mcg/1.0ml Recombinant Hepatitis B Vaccine
n=435 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
10mcg/1.0ml Recombinant Hepatitis B Vaccine
n=222 Participants
300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
Total
n=1091 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
42.7 years
n=5 Participants
|
43.3 years
n=7 Participants
|
42.6 years
n=5 Participants
|
43.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
561 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
208 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
530 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one month after the second vaccinationPopulation: Accroding to Protocol set
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination
Outcome measures
| Measure |
60mcg/1.0ml Recombinant Hepatitis B Vaccine
n=428 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
30mcg/1.0ml Recombinant Hepatitis B Vaccine
n=426 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
10mcg/1.0ml Recombinant Hepatitis B Vaccine
n=217 Participants
300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
|---|---|---|---|
|
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
|
394 participants
Interval 93.7 to 97.7
|
371 participants
Interval 89.6 to 94.8
|
180 participants
|
PRIMARY outcome
Timeframe: one month after the third vaccinationQuantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination
Outcome measures
| Measure |
60mcg/1.0ml Recombinant Hepatitis B Vaccine
n=428 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
30mcg/1.0ml Recombinant Hepatitis B Vaccine
n=426 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
10mcg/1.0ml Recombinant Hepatitis B Vaccine
n=217 Participants
300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
|---|---|---|---|
|
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
|
411 participants
|
394 participants
|
187 participants
|
SECONDARY outcome
Timeframe: one month after the first vaccinationQuantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after first vaccination
Outcome measures
| Measure |
60mcg/1.0ml Recombinant Hepatitis B Vaccine
n=428 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
30mcg/1.0ml Recombinant Hepatitis B Vaccine
n=426 Participants
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
10mcg/1.0ml Recombinant Hepatitis B Vaccine
n=217 Participants
300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
|
|---|---|---|---|
|
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
|
367 participants
|
331 participants
|
158 participants
|
SECONDARY outcome
Timeframe: within the first 30 days after first vaccinationassessment of the local and systemic adverse reaction within the first 30 days after first vaccination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within the first 30 days after second vaccinationassessment of the local and systemic adverse reaction within the first 30 days after second vaccination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within the first 30 days after third vaccinationassessment of the local and systemic adverse reaction within the first 30 days after third vaccination
Outcome measures
Outcome data not reported
Adverse Events
60mcg/1.0ml Recombinant Hepatitis B Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30mcg/1.0ml Recombinant Hepatitis B Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10mcg/1.0ml Recombinant Hepatitis B Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Fengcai Zhu
Jiangsu Provincial Center for Disease Control and Prevention
Phone: #86-25-83759418
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place