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Trial record 1 of 7 for:    Recombivax HB | Hepatitis B | Phase 3
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A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

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: NCT00414050
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : April 14, 2009
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Hepatitis B
Interventions Biological: Modified Process Hepatitis B Vaccine (Experimental)
Biological: Hepatitis B Vaccine (Recombinant)
Enrollment 1718
Recruitment Details 15-Nov-2006 (First Participant Enrolled in Study) to 24-Oct-2007 (Last Participant had their Last Visit). Last participant completed follow-up: 16-Oct-2007.This study was conducted at 15 sites; 14 in Finland and 1 in Norway.
Pre-assignment Details  
Arm/Group Title Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B®
Hide Arm/Group Description Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Period Title: Overall Study
Started 431 427 429 431
Received Vaccination 1 431 426 429 431
Received Vaccination 2 425 421 425 425
Received Vaccination 3 424 419 425 424
Completed 422 419 423 423
Not Completed 9 8 6 8
Reason Not Completed
Adverse Event             1             1             1             1
Lost to Follow-up             2             2             1             1
Withdrawal by Subject             5             3             2             4
Subject discontinued for other reason             1             2             2             1
Subject Moved             0             0             0             1
Arm/Group Title Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B® Total
Hide Arm/Group Description Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. Total of all reporting groups
Overall Number of Baseline Participants 431 427 429 431 1718
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 431 participants 427 participants 429 participants 431 participants 1718 participants
63.2  (10.18) 62.9  (10.15) 63.3  (9.83) 62.8  (9.81) 63.1  (9.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 427 participants 429 participants 431 participants 1718 participants
Female
190
  44.1%
217
  50.8%
208
  48.5%
201
  46.6%
816
  47.5%
Male
241
  55.9%
210
  49.2%
221
  51.5%
230
  53.4%
902
  52.5%
1.Primary Outcome
Title The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
Hide Description The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
Time Frame 7 months of age (1 month after 3 doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.
Arm/Group Title Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B®
Hide Arm/Group Description:
Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Overall Number of Participants Analyzed 405 406 398 400
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.3
(98.3 to 100)
98.5
(97.2 to 99.8)
100
(99.9 to 100)
99.5
(98.7 to 100)
2.Secondary Outcome
Title Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®
Hide Description Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.
Time Frame 7 months of age (1 month after 3 doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.
Arm/Group Title Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B®
Hide Arm/Group Description:
Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Overall Number of Participants Analyzed 405 406 398 400
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
748.2
(672.0 to 833.1)
376.8
(331.4 to 428.5)
981.5
(891.0 to 1081.2)
556.6
(491.8 to 629.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modified Process Hepatitis B Vaccine 5 µg (Micrograms), RECOMBIVAX™ Hepatitis B Vaccine
Comments Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was >= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
1.69 to 2.35
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination
Adverse Event Reporting Description All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
 
Arm/Group Title Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B®
Hide Arm/Group Description Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
All-Cause Mortality
Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/430 (2.56%)      2/424 (0.47%)      6/429 (1.40%)      8/428 (1.87%)    
Blood and lymphatic system disorders         
Thrombocytopenia  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Gastrointestinal disorders         
Constipation  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Gastrooesophageal reflux disease  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
General disorders         
Pyrexia  1  0/430 (0.00%)  0 0/424 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Sudden infant death syndrome  1  0/430 (0.00%)  0 1/424 (0.24%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Infections and infestations         
Bacterial infection  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Bronchiolitis  1  0/430 (0.00%)  0 0/424 (0.00%)  0 2/429 (0.47%)  2 1/428 (0.23%)  1
Gastroenteritis  1  1/430 (0.23%)  1 0/424 (0.00%)  0 1/429 (0.23%)  1 2/428 (0.47%)  2
Otitis media  1  0/430 (0.00%)  0 0/424 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  2
Pyelonephritis  1  1/430 (0.23%)  2 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Pyelonephritis acute  1  2/430 (0.47%)  2 0/424 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Respiratory syncytial virus bronchiolitis  1  0/430 (0.00%)  0 0/424 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Respiratory tract infection  1  1/430 (0.23%)  1 0/424 (0.00%)  0 2/429 (0.47%)  2 0/428 (0.00%)  0
Upper respiratory tract infection  1  1/430 (0.23%)  1 1/424 (0.24%)  1 0/429 (0.00%)  0 1/428 (0.23%)  1
Respiratory syncytial virus infection  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Investigations         
Nutritional condition abnormal  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Metabolism and nutrition disorders         
Malnutrition  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Psychiatric disorders         
Crying  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Reproductive system and breast disorders         
Epididymitis  1  1/430 (0.23%)  1 0/424 (0.00%)  0 0/429 (0.00%)  0 0/428 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/430 (0.00%)  0 0/424 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Cough  1  0/430 (0.00%)  0 0/424 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Bronchitis chronic  1  0/430 (0.00%)  0 0/424 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Modified Process Hepatitis B Vaccine 5 µg (Micrograms) RECOMBIVAX™ Hepatitis B Vaccine Modified Process Hepatitis B Vaccine 10 µg ENGERIX-B®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   308/430 (71.63%)      294/424 (69.34%)      276/429 (64.34%)      288/428 (67.29%)    
Eye disorders         
Conjunctivitis  1  9/430 (2.09%)  11 14/424 (3.30%)  14 10/429 (2.33%)  10 22/428 (5.14%)  23
Gastrointestinal disorders         
Diarrhoea  1  30/430 (6.98%)  37 26/424 (6.13%)  36 26/429 (6.06%)  31 18/428 (4.21%)  26
General disorders         
Irritability  1  114/430 (26.51%)  169 109/424 (25.71%)  157 91/429 (21.21%)  138 107/428 (25.00%)  139
Pyrexia  1  62/430 (14.42%)  78 57/424 (13.44%)  65 56/429 (13.05%)  68 53/428 (12.38%)  65
Injection-site erythema  1  128/430 (29.77%)  169 117/424 (27.59%)  160 116/429 (27.04%)  153 94/428 (21.96%)  124
Injection-site pain  1  79/430 (18.37%)  117 73/424 (17.22%)  96 60/429 (13.99%)  90 66/428 (15.42%)  92
Injection-site induration  1  25/430 (5.81%)  29 15/424 (3.54%)  19 24/429 (5.59%)  26 8/428 (1.87%)  9
Injection-site swelling  1  78/430 (18.14%)  109 85/424 (20.05%)  111 87/429 (20.28%)  110 65/428 (15.19%)  98
Infections and infestations         
Upper respiratory tract infection  1  32/430 (7.44%)  35 26/424 (6.13%)  27 25/429 (5.83%)  25 23/428 (5.37%)  25
Rhinitis  1  53/430 (12.33%)  57 47/424 (11.08%)  54 59/429 (13.75%)  68 51/428 (11.92%)  57
Psychiatric disorders         
Crying  1  41/430 (9.53%)  51 39/424 (9.20%)  49 39/429 (9.09%)  48 41/428 (9.58%)  48
Respiratory, thoracic and mediastinal disorders         
Cough  1  21/430 (4.88%)  21 15/424 (3.54%)  18 17/429 (3.96%)  19 25/428 (5.84%)  26
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00414050    
Other Study ID Numbers: V232-057
2006_053
2006-001638-42 ( EudraCT Number )
First Submitted: December 20, 2006
First Posted: December 21, 2006
Results First Submitted: October 15, 2008
Results First Posted: April 14, 2009
Last Update Posted: May 23, 2017