Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006_053 | |||
| 2006-001638-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Process Hepatitis B vaccine 5 μg | Experimental | Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
|
| RECOMBIVAX HB™ Hepatitis B Vaccine | Active Comparator | Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
|
| Modified Process Hepatitis B vaccine 10 μg | Experimental | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
|
| ENGERIX-B® | Active Comparator | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Process Hepatitis B Vaccine (Experimental) | Biological | Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm). |
| Measure | Description | Time Frame |
|---|---|---|
| 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® | 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%. | 7 months of age (1 month after 3 doses) |
| Measure | Description | Time Frame |
|---|---|---|
| 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® | Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood. | 7 months of age (1 month after 3 doses) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21552183 | Result | Vesikari T, Martin JC, Liss CL, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Modified Process Hepatitis B Vaccine 5 µg (Micrograms) | Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| FG001 | RECOMBIVAX™ Hepatitis B Vaccine | Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| FG002 | Modified Process Hepatitis B Vaccine 10 µg | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| FG003 | ENGERIX-B® | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Modified Process Hepatitis B Vaccine 5 µg (Micrograms) | Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| BG001 | RECOMBIVAXâ„¢ Hepatitis B Vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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® | 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%. | Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges. | Posted | Number | 95% Confidence Interval | Percentage of participants | 7 months of age (1 month after 3 doses) |
|
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
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™.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Process Hepatitis B Vaccine 5 µg (Micrograms) | Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nutritional condition abnormal | Investigations | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1 800 672 6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| C075655 | Recombivax HB |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hepatitis B Vaccine (Recombinant) | Biological | RECOMBIVAX HBâ„¢ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months. |
|
|
| Hepatitis B Vaccine (Recombinant) | Biological | ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months |
|
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Subject discontinued for other reason |
|
| Subject Moved |
|
Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
| BG002 | Modified Process Hepatitis B Vaccine 10 µg | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| BG003 | ENGERIX-B® | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| BG004 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| OG001 | RECOMBIVAX™ Hepatitis B Vaccine | Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| OG002 | Modified Process Hepatitis B Vaccine 10 µg | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| OG003 | ENGERIX-B® | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
|
|
| Secondary | 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® | Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood. | Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 7 months of age (1 month after 3 doses) |
|
|
|
|
| 11 |
| 430 |
| 308 |
| 430 |
| EG001 | RECOMBIVAX™ Hepatitis B Vaccine | Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. | 2 | 424 | 294 | 424 |
| EG002 | Modified Process Hepatitis B Vaccine 10 µg | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. | 6 | 429 | 276 | 429 |
| EG003 | ENGERIX-B® | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. | 8 | 428 | 288 | 428 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Sudden infant death syndrome | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Injection-site erythema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Injection-site pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Injection-site induration | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Injection-site swelling | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
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.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |