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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_513 |
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To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Modified process Hib/Hep B vaccine |
|
| 2 | Active Comparator | COMVAX™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Modified Process Vaccine | Biological | Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. | 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 Month 11 (1 month after the third dose) | 11 months (1 month after the third dose) |
| The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose. | Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose). | 11 months (1 month after the third dose) |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose) | 0-11 months (recorded from first dose until the participant completes or discontinues) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21875633 | Result | Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schodel FP, Bhuyan PK. Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants. Vaccine. 2011 Oct 19;29(45):7942-8. doi: 10.1016/j.vaccine.2011.08.071. Epub 2011 Aug 27. |
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Participants excluded for history of or prior vaccination for hepatitis B (Hep B) or Haemophilus influenzae Type B (Hib) disease and for administration of blood products. Participants also excluded if mother received Hep B, Hib vaccine, or blood products 6 months prior to participant birth.
06-Dec-2006 (First Participant Enrolled in Study) to 03-Jun-2008 (Last Participant had their Last Visit).
This study was conducted at 27 sites: 17 in Canada (16 of which were active sites) and 10 in Finland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Process Vaccine | Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms) |
| FG001 | COMVAX™ | COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Process Vaccine | Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms) 1 participant randomized but not vaccinated in the Modified Process Vaccine group; overall N is 269, not 270. |
| BG001 | COMVAX™ |
| 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 Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. | 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 Month 11 (1 month after the third dose) | Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol. | Posted | Number | Participants | 11 months (1 month after the third dose) |
|
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| 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 Vaccine | Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication error | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Comparator: COMVAX™ | Biological | COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months. |
|
| The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose. | The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose) | 11 months (1 month after the third dose) |
| The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose. | Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose) | 11 months (1 month after the third dose) |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Subject Randomized but Not Vaccinated |
|
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
3 participants in the COMVAX™ group vaccinated but not randomized; overall N is 276, not 273 - due to issues randomizing via IVRS, in violation, all 3 participants were vaccinated as randomly assigned by the Investigator.
| BG002 | Total | Total of all reporting groups |
| Days |
|
| Age, Continuous | Mean | Full Range | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms) |
|
|
|
| Primary | The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose. | Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose). | Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 11 months (1 month after the third dose) |
|
|
|
|
| Secondary | The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose) | Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up. | Posted | Number | Participants | 0-11 months (recorded from first dose until the participant completes or discontinues) |
|
|
|
| Secondary | The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose. | The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose) | Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol. | Posted | Number | Participants | 11 months (1 month after the third dose) |
|
|
|
|
| Secondary | The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose. | Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose) | Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol. | Posted | Geometric Mean | 95% Confidence Interval | µg /mL | 11 months (1 month after the third dose) |
|
|
|
| 0 |
| 259 |
| EG001 | COMVAX™ | COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms) | 3 | 264 |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Body temperature increased | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site hematoma | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 11.0 | 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.
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Percentage of Seroprotected Participants |
| 92.1 |
| 95 |
| 87.8 |
| 95.3 |
Exact binomial confidence interval |
| No |
| Superiority or Other |