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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_076 |
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This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.
In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated.
In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was collected after each dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1) | Experimental | Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
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| PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1) | Experimental | Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
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| VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1) | Experimental | Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
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| PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1) | Experimental | Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: VAQTA™ | Biological | VAQTA™ (Hepatitis A Vaccine, Inactivated). Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity Rate (SPR) to Hepatitis A | SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA). | 4 weeks after dose 2 of VAQTA™ |
| Antibody Response Rate to Haemophilus Influenzae Type b (Hib) | Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL. The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™. | 4 weeks postvaccination with PedvaxHIB™ |
| Number of Participants With Adverse Events (AE) | Systemic and injection site AEs were collected from participants receiving
Safety data was collected on a standardized Vaccination Report Card (VRC) following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE. | Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs |
| Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™. IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL. IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL. IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL. |
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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 |
|---|---|---|---|
| 26308112 | Result | Petrecz M, Ramsey KP, Stek JE, Martin JC, Klopfer SO, Kuter B, Schodel FP, Lee AW. Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children. Hum Vaccin Immunother. 2016;12(2):503-11. doi: 10.1080/21645515.2015.1080395. |
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For this study: Visit 1 was on Day 1 (for Stage I and Stage II). Visit 2 was at Week 4 (Stage I) and Week 2 (Stage II). Visit 3 was at Week 24/Week 28 (Stage I) and Week 24 (Stage II). Visit 4 was at Week 28/Week 32 (Stage I) and Week 26 (Stage II). For safety, participants were followed for 14 days after each vaccination (safety follow-up [F/U]).
In Stage I, a total of 620 participants were randomized to receive study vaccinations. However for 3 participants, the Health Insurance Portability and Accountability Act (HIPAA) and/or Informed Consent Form was not signed by the parents in error. Therefore a total of 617 participants were included in Stage I. 654 participants started Stage II.
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| ID | Title | Description |
|---|---|---|
| FG000 | VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
| FG001 | PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 1 (Stage I and Stage II) |
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| VAQTA™/VAQTA™ (Stage 2) | Experimental | Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered. |
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| Comparator: Infanrix™ | Biological | Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline). One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit. |
|
| Comparator: PedvaxHIB™ | Biological | PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]). One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit. |
|
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| 4 weeks postvaccination with Infanrix™ |
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
| FG002 | VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
| FG003 | PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) | Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
| FG004 | VAQTA™/ VAQTA™ (Stage 2) | Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered. |
| COMPLETED |
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| NOT COMPLETED |
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| Visit 2 (Stage I and Stage II) |
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| Visit 3 (Stage I and Stage II) |
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| Visit 4 (Stage I and Stage II) |
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| ID | Title | Description |
|---|---|---|
| BG000 | VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
| BG001 | PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
| BG002 | VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
| BG003 | PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) | Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
| BG004 | VAQTA™/ VAQTA™ (Stage 2) | Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Months between the birthdate and consent date. | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||
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| Primary | Seropositivity Rate (SPR) to Hepatitis A | SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA). | The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 weeks after dose 2 of VAQTA™ |
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| Primary | Antibody Response Rate to Haemophilus Influenzae Type b (Hib) | Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL. The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™. | The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 weeks postvaccination with PedvaxHIB™ |
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| Primary | Number of Participants With Adverse Events (AE) | Systemic and injection site AEs were collected from participants receiving
Safety data was collected on a standardized Vaccination Report Card (VRC) following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE. | Participants administered at least one dose of vaccine, for whom follow-up was available. | Posted | Number | Participants | Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs |
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| Primary | Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™. IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL. IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL. IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL. | The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | ELISA units per mL (ELU/mL) | 4 weeks postvaccination with Infanrix™ |
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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 | VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. | 0 | 150 | 116 | 150 | ||
| EG001 | PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. | 2 | 145 | 74 | 145 | ||
| EG002 | VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. | 0 | 152 | 123 | 152 | ||
| EG003 | PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I) | Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. | 2 | 146 | 88 | 146 | ||
| EG004 | VAQTA™/ VAQTA™ (Stage 2) | Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered. | 2 | 641 | 426 | 641 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| FOREIGN BODY | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| TEETHING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA 13.0 | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
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| INJECTION SITE SWELLING | General disorders | MedDRA 13.0 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 13.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Lost during safety F/U |
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| Subject moved during safety F/U |
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| Withdrew consent during safety F/U |
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| Other reasons during safety F/U |
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| Protocol deviation after safety F/U |
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| Lost after safety F/U |
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| Withdrew consent after safety F/U |
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| Other reasons after safety F/U] |
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| Protocol deviation (Stage II) |
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| Lost (Stage II) |
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| Moved (Stage II) |
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| Withdrew consent (Stage II) |
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| Other reasons (Stage II) |
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| Lost during safety F/U |
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| Withdrew consent during safety F/U |
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| Other reasons during safety F/U |
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| Lost after safety F/U |
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| Withdrew consent after safety F/U] |
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| Moved after safety F/U |
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| Other reasons after safety F/U |
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| Male |
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Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
| OG003 | PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) | Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
| OG004 | VAQTA™/ VAQTA™ (Stage 2) | Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered. |
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| OG002 | VAQTA™/VAQTA™ | All participants receiving VAQTA™ alone (from Stage II) on Day 1 and Day 24. |
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| OG002 | VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered. |
| OG003 | PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) | Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered. |
| OG004 | VAQTA™/ VAQTA™ (Stage 2) | Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered. |
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