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Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393523
Recruitment Status : Completed
First Posted : October 27, 2006
Results First Posted : October 12, 2009
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Hepatitis B
Interventions Biological: Comparator: Modified Process Hepatitis B Vaccine
Biological: Comparator: Comparator: ENGERIX-B
Enrollment 1478
Recruitment Details

This study was conducted at 77 primary study sites in Spain and 1 study site in Canada.

Date of first subject visit: 26-Sep-2006; Date of last subject visit: 23-June-2008

Pre-assignment Details To be eligible for enrollment in the study, participants were to have received a primary series of 3 doses of the same type of hepatitis B vaccine (either RECOMBIVAX HB or ENGERIX-B) during the first year of life.
Arm/Group Title Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) Modified Process Hepatitis B Vaccine (Group 5)
Hide Arm/Group Description Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
Period Title: Overall Study
Started 376 375 353 354 20
Vaccination Visit 1 374 375 349 352 20
Completed 364 366 349 348 19
Not Completed 12 9 4 6 1
Reason Not Completed
Lost to Follow-up             0             0             0             2             1
Protocol Violation             6             2             0             1             0
Withdrawal by Subject             6             7             2             3             0
Difficulties in specimen collection             0             0             1             0             0
Vaccine supply issue             0             0             1             0             0
Arm/Group Title Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) Modified Process Hepatitis B Vaccine (Group 5) Total
Hide Arm/Group Description Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) Total of all reporting groups
Overall Number of Baseline Participants 376 375 353 354 20 1478
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 376 participants 375 participants 353 participants 354 participants 20 participants 1478 participants
5.7  (0.92) 5.7  (0.92) 5.3  (1.05) 5.4  (0.98) 4.3  (0.66) 5.5  (0.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants 375 participants 353 participants 354 participants 20 participants 1478 participants
Female
172
  45.7%
186
  49.6%
179
  50.7%
161
  45.5%
13
  65.0%
711
  48.1%
Male
204
  54.3%
189
  50.4%
174
  49.3%
193
  54.5%
7
  35.0%
767
  51.9%
1.Primary Outcome
Title Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
Hide Description Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Time Frame 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Arm/Group Title Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
Hide Arm/Group Description:
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
Overall Number of Participants Analyzed 340 333
Measure Type: Number
Unit of Measure: Participants
323 305
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modified Process Hepatitis B Vaccine Booster (Group 1)
Comments The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments

Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be > 90% (P-Value < .024).

Since only one group met the criteria, that group was retested at α=.012.

Method Hochberg's step up
Comments The primary hypothesis was evaluated using Hochberg’s step up approach to control multiplicity.
Method of Estimation Estimation Parameter Seroprotection rate (SPR)
Estimated Value 95.0
Confidence Interval 95.2%
92.1 to 97.1
Estimation Comments Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Modified Process Hepatitis B Vaccine Booster (Group 1)
Comments The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be > 90% (P-Value < .024). Since only one group met the criteria, that group was retested at α=.012.
Method Hochberg's step up
Comments The primary hypothesis was evaluated using Hochberg’s step up approach to control multiplicity.
Method of Estimation Estimation Parameter Seroprotection rate (SPR)
Estimated Value 95.0
Confidence Interval 97.6%
91.6 to 97.3
Estimation Comments Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
Comments The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments

Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be > 90% (P-Value < .024).

Since only one group met the criteria, that group was retested at α=.012.

Method Hochberg's step up
Comments The primary hypothesis was evaluated using Hochberg’s step up approach to control multiplicity.
Method of Estimation Estimation Parameter Seroprotection rate (SPR)
Estimated Value 91.6
Confidence Interval 95.2%
88.0 to 94.4
Estimation Comments Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL
2.Secondary Outcome
Title Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
Hide Description Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Time Frame 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Arm/Group Title Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
Hide Arm/Group Description:
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
Overall Number of Participants Analyzed 338 328
Measure Type: Number
Unit of Measure: Participants
329 313
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modified Process Hepatitis B Vaccine Booster (Group 3)
Comments The purpose of the secondary analysis is to demonstrate that there is an adequate SPR in subjects who received a primary vaccination series of ENGERIX-B™ and a booster dose of modified process hepatitis B vaccine. An adequate response requires the lower bound of the two-sided 95% confidence interval for the SPR to exceed 90%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Seroprotection Rate (SPR)
Estimated Value 97.3
Confidence Interval 95%
95.0 to 98.8
Estimation Comments

Exact binomial confidence interval

Seroprotection Rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL

3.Other Pre-specified Outcome
Title Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
Hide Description Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
Time Frame 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Arm/Group Title Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
Hide Arm/Group Description:
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
Overall Number of Participants Analyzed 340 333
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
476.9
(380.7 to 597.3)
561.2
(435.6 to 723.1)
4.Other Pre-specified Outcome
Title Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
Hide Description Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
Time Frame 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Arm/Group Title Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
Hide Arm/Group Description:
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
Overall Number of Participants Analyzed 338 328
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1424.0
(1131.1 to 1792.8)
1216.1
(923.6 to 1601.2)
Time Frame [Not Specified]
Adverse Event Reporting Description Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
 
Arm/Group Title Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) Modified Process Hepatitis B Vaccine (Group 5)
Hide Arm/Group Description Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
All-Cause Mortality
Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) Modified Process Hepatitis B Vaccine (Group 5)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) Modified Process Hepatitis B Vaccine (Group 5)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/369 (0.00%)   0/368 (0.00%)   0/344 (0.00%)   2/342 (0.58%)   0/19 (0.00%) 
Blood and lymphatic system disorders           
Lymphadenitis * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Infections and infestations           
Tonsillitis * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Modified Process Hepatitis B Vaccine Booster (Group 1) ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) Modified Process Hepatitis B Vaccine Booster (Group 3) ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) Modified Process Hepatitis B Vaccine (Group 5)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   214/369 (57.99%)   192/368 (52.17%)   198/344 (57.56%)   194/342 (56.73%)   9/19 (47.37%) 
Blood and lymphatic system disorders           
Lymphadenitis * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Lymphadenopathy * 1  1/369 (0.27%)  1/368 (0.27%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Ear and labyrinth disorders           
Ear Pain * 1  5/369 (1.36%)  5/368 (1.36%)  6/344 (1.74%)  4/342 (1.17%)  0/19 (0.00%) 
Motion Sickness * 1  1/369 (0.27%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Endocrine disorders           
Eye Swelling * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Eye disorders           
Conjunctivitis * 1  2/369 (0.54%)  1/368 (0.27%)  2/344 (0.58%)  1/342 (0.29%)  0/19 (0.00%) 
Conjunctivitis allergic * 1  1/369 (0.27%)  0/368 (0.00%)  2/344 (0.58%)  2/342 (0.58%)  0/19 (0.00%) 
Eye Discharge * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  2/369 (0.54%)  9/368 (2.45%)  4/344 (1.16%)  6/342 (1.75%)  1/19 (5.26%) 
Abdominal pain upper * 1  3/369 (0.81%)  2/368 (0.54%)  2/344 (0.58%)  2/342 (0.58%)  1/19 (5.26%) 
Aphthous stomatitis * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  3/342 (0.88%)  0/19 (0.00%) 
Constipation * 1  0/369 (0.00%)  1/368 (0.27%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Dental caries * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Diarrhea * 1  9/369 (2.44%)  2/368 (0.54%)  8/344 (2.33%)  8/342 (2.34%)  0/19 (0.00%) 
Flatulence  1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Gastritis * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  2/342 (0.58%)  0/19 (0.00%) 
Lip dry * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Nausea * 1  1/369 (0.27%)  0/368 (0.00%)  1/344 (0.29%)  2/342 (0.58%)  0/19 (0.00%) 
Odynophagia * 1  1/369 (0.27%)  1/368 (0.27%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Stomatitis * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Toothache * 1  1/369 (0.27%)  0/368 (0.00%)  2/344 (0.58%)  1/342 (0.29%)  0/19 (0.00%) 
Vomiting * 1  13/369 (3.52%)  1/368 (0.27%)  7/344 (2.03%)  13/342 (3.80%)  0/19 (0.00%) 
General disorders           
Asthenia * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Discomfort * 1  3/369 (0.81%)  0/368 (0.00%)  1/344 (0.29%)  2/342 (0.58%)  0/19 (0.00%) 
Fatigue * 1  2/369 (0.54%)  3/368 (0.82%)  2/344 (0.58%)  2/342 (0.58%)  0/19 (0.00%) 
Hypothermia * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Irritability * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Malaise * 1  2/369 (0.54%)  1/368 (0.27%)  2/344 (0.58%)  1/342 (0.29%)  0/19 (0.00%) 
Pain * 1  1/369 (0.27%)  1/368 (0.27%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Pyrexia * 1  22/369 (5.96%)  20/368 (5.43%)  17/344 (4.94%)  32/342 (9.36%)  1/19 (5.26%) 
Vessel puncture site pain * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Bruising, Injection site for hepatitis B vaccine * 1  1/369 (0.27%)  0/368 (0.00%)  1/344 (0.29%)  2/342 (0.58%)  0/19 (0.00%) 
Erythema, Injection site for hepatitis B vaccine  1  37/369 (10.03%)  37/368 (10.05%)  30/344 (8.72%)  26/342 (7.60%)  2/19 (10.53%) 
Hematoma, Injection site for hepatitis B vaccine * 1  0/369 (0.00%)  3/368 (0.82%)  3/344 (0.87%)  3/342 (0.88%)  0/19 (0.00%) 
Hypersensitivity, Injection site for hepatitis B vaccine * 1  0/369 (0.00%)  2/368 (0.54%)  3/344 (0.87%)  2/342 (0.58%)  0/19 (0.00%) 
Induration, Injection site for hepatitis B vaccine * 1  3/369 (0.81%)  1/368 (0.27%)  1/344 (0.29%)  2/342 (0.58%)  0/19 (0.00%) 
Edema, Injection site for hepatitis B vaccine * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Pain, Injection site for hepatitis B vaccine  1  129/369 (34.96%)  107/368 (29.08%)  93/344 (27.03%)  95/342 (27.78%)  6/19 (31.58%) 
Paraesthesia, Injection site for hepatitis B vaccine * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Pruritus, Injection site for hepatitis B vaccine * 1  6/369 (1.63%)  3/368 (0.82%)  3/344 (0.87%)  3/342 (0.88%)  0/19 (0.00%) 
Scar, Injection site for hepatitis B vaccine * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Swelling, Injection site for hepatitis B vaccine  1  54/369 (14.63%)  38/368 (10.33%)  40/344 (11.63%)  25/342 (7.31%)  3/19 (15.79%) 
Vesicles, Injection site for hepatitis B vaccine * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Warmth, Injection site for hepatitis B vaccine * 1  3/369 (0.81%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Immune system disorders           
Hypersensitivity * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Infections and infestations           
Bronchitis * 1  1/369 (0.27%)  1/368 (0.27%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Cystitis * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Ear infection * 1  3/369 (0.81%)  2/368 (0.54%)  3/344 (0.87%)  6/342 (1.75%)  0/19 (0.00%) 
Enterobiasis * 1  0/369 (0.00%)  2/368 (0.54%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Fungal infection * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Gastroenteritis * 1  3/369 (0.81%)  4/368 (1.09%)  9/344 (2.62%)  3/342 (0.88%)  0/19 (0.00%) 
Herpes virus infection * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Impetigo * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Infectious mononucleosis * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Influenza * 1  4/369 (1.08%)  0/368 (0.00%)  2/344 (0.58%)  0/342 (0.00%)  0/19 (0.00%) 
Laryngitis * 1  1/369 (0.27%)  2/368 (0.54%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Nasopharyngitis * 1  17/369 (4.61%)  12/368 (3.26%)  12/344 (3.49%)  13/342 (3.80%)  0/19 (0.00%) 
Otitis media * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  2/342 (0.58%)  0/19 (0.00%) 
Otitis media acute * 1  2/369 (0.54%)  0/368 (0.00%)  3/344 (0.87%)  1/342 (0.29%)  0/19 (0.00%) 
Pharyngitis * 1  11/369 (2.98%)  4/368 (1.09%)  5/344 (1.45%)  4/342 (1.17%)  0/19 (0.00%) 
Pharyngotonsillitis * 1  2/369 (0.54%)  0/368 (0.00%)  0/344 (0.00%)  2/342 (0.58%)  0/19 (0.00%) 
Pneumonia * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Respiratory tract infection * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Rhinitis * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Scarlet fever * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Sinusitis * 1  1/369 (0.27%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Skin infection * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Tonsillitis * 1  7/369 (1.90%)  11/368 (2.99%)  1/344 (0.29%)  7/342 (2.05%)  0/19 (0.00%) 
Tonsillitis streptococcal * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  2/342 (0.58%)  0/19 (0.00%) 
Tooth infection * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Upper respiratory tract infection * 1  2/369 (0.54%)  1/368 (0.27%)  8/344 (2.33%)  8/342 (2.34%)  0/19 (0.00%) 
Varicella * 1  0/369 (0.00%)  1/368 (0.27%)  2/344 (0.58%)  1/342 (0.29%)  0/19 (0.00%) 
Viral infection * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  2/19 (10.53%) 
Viral upper respiratory tract infection * 1  3/369 (0.81%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Vulvovaginitis * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Injury, poisoning and procedural complications           
Arthropod bite * 1  0/369 (0.00%)  0/368 (0.00%)  2/344 (0.58%)  0/342 (0.00%)  0/19 (0.00%) 
Arthropod sting * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Bite * 1  1/369 (0.27%)  1/368 (0.27%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Chillblains * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Contusion * 1  3/369 (0.81%)  2/368 (0.54%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Excoriation * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Face injury * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Head injury * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Joint sprain * 1  0/369 (0.00%)  0/368 (0.00%)  2/344 (0.58%)  1/342 (0.29%)  0/19 (0.00%) 
Open wound * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Wound * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Investigations           
Alanine aminotransferase increased * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Aspartate aminotransferase increased * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Metabolism and nutrition disorders           
Anorexia * 1  2/369 (0.54%)  0/368 (0.00%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Arthralgia * 1  5/369 (1.36%)  2/368 (0.54%)  0/344 (0.00%)  0/342 (0.00%)  1/19 (5.26%) 
Bone pain * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Epiphysiolysis * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Musculoskeletal stiffness * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Myalgia * 1  2/369 (0.54%)  1/368 (0.27%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Neck pain * 1  1/369 (0.27%)  2/368 (0.54%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Pain in extremity * 1  5/369 (1.36%)  0/368 (0.00%)  3/344 (0.87%)  0/342 (0.00%)  0/19 (0.00%) 
Nervous system disorders           
Aphonia * 1  1/369 (0.27%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Headache * 1  16/369 (4.34%)  18/368 (4.89%)  19/344 (5.52%)  14/342 (4.09%)  0/19 (0.00%) 
Psychiatric disorders           
Insomnia * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Nightmare * 1  1/369 (0.27%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma * 1  0/369 (0.00%)  0/368 (0.00%)  3/344 (0.87%)  3/342 (0.88%)  0/19 (0.00%) 
Cough * 1  13/369 (3.52%)  10/368 (2.72%)  22/344 (6.40%)  12/342 (3.51%)  1/19 (5.26%) 
Dysphonia * 1  0/369 (0.00%)  1/368 (0.27%)  1/344 (0.29%)  0/342 (0.00%)  0/19 (0.00%) 
Epistaxis * 1  1/369 (0.27%)  0/368 (0.00%)  2/344 (0.58%)  2/342 (0.58%)  0/19 (0.00%) 
Increased upper airway secretion * 1  3/369 (0.81%)  2/368 (0.54%)  1/344 (0.29%)  3/342 (0.88%)  0/19 (0.00%) 
Nasal congestion * 1  3/369 (0.81%)  2/368 (0.54%)  0/344 (0.00%)  2/342 (0.58%)  0/19 (0.00%) 
Pharyngolaryngeal pain * 1  7/369 (1.90%)  6/368 (1.63%)  9/344 (2.62%)  5/342 (1.46%)  0/19 (0.00%) 
Rhinalgia * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Rhinitis allergic * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Rhinitis seasonal * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Rhinorrhoea * 1  1/369 (0.27%)  2/368 (0.54%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders           
Acne * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  2/342 (0.58%)  0/19 (0.00%) 
Dermatitis * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Dermatitis atopic * 1  2/369 (0.54%)  2/368 (0.54%)  3/344 (0.87%)  4/342 (1.17%)  0/19 (0.00%) 
Dermatitis contact * 1  0/369 (0.00%)  0/368 (0.00%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Eczema * 1  2/369 (0.54%)  0/368 (0.00%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Erythema * 1  1/369 (0.27%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Prurigo * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Pruritus * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  1/342 (0.29%)  0/19 (0.00%) 
Rash * 1  3/369 (0.81%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  1/19 (5.26%) 
Urticaria * 1  0/369 (0.00%)  0/368 (0.00%)  2/344 (0.58%)  1/342 (0.29%)  0/19 (0.00%) 
Vascular disorders           
Hematoma * 1  0/369 (0.00%)  0/368 (0.00%)  1/344 (0.29%)  1/342 (0.29%)  0/19 (0.00%) 
Pallor * 1  0/369 (0.00%)  1/368 (0.27%)  0/344 (0.00%)  0/342 (0.00%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00393523    
Other Study ID Numbers: V232-058
2006_040
First Submitted: October 25, 2006
First Posted: October 27, 2006
Results First Submitted: May 27, 2009
Results First Posted: October 12, 2009
Last Update Posted: April 12, 2017