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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1153-4027 | Registry Identifier | UTN | |
| JapicCTI-142454 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.
The vaccine being tested in this study is called TAK-816. TAK-816 was being tested to evaluate its safety and immune response after intramuscular (IM) injection with TAK-816. This study evaluated adverse events and the seroprotection rate and geometric mean titer (GMT) of anti-polyribosylribitol phosphate (PRP)-antibodies in participants who were administered TAK-816 IM.
The study enrolled 31 participants. All participants received 3 doses of TAK-816 IM at 4-week intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the third dose of the primary vaccination.
This multi-center trial was conducted in Japan. The overall time to participate in this study was 64 weeks. Participants made multiple visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-816 0.5 mL | Experimental | Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-816 | Biological | TAK-816 intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions. | For 64 Weeks |
| Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia) | Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia. | For 64 Weeks |
| Number of Participants With Adverse Reactions Related to Local Reactions | Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness). | For 64 Weeks |
| Number of Participants With Adverse Reactions Related to Systemic Reactions | Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness). | For 64 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL | Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity. | For 64 weeks |
| Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Manager | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kumagaya-shi | Saitama | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29685594 | Derived | Togashi T, Mitsuya N, Sumino S, Takanami Y. Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial. Vaccine. 2018 May 17;36(21):2968-2972. doi: 10.1016/j.vaccine.2018.04.040. Epub 2018 Apr 20. |
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Participants received open-label TAK-816 0.5 mL vaccinations, 3 initial doses and 1 booster.
Participants took part in the study at 4 investigative sites in Japan from 13 March 2014 to 25 March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-816 0.5 mL | Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set (FAS) - all participants who received at least 1 dose of the study vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-816 0.5 mL | Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization. |
| 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 | Number of Participants With Adverse Events | Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions. | Full Analysis Set (FAS) included all participants who received at least 1 dose of the study vaccination. | Posted | Number | participants | For 64 Weeks |
|
For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 | TAK-816 0.5 mL | Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity. |
| For 64 weeks |
| Geometric Mean Titer (GMT) of Anti-PRP Antibody | Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity. | For 64 weeks |
| Fuchu-shi |
| Tokyo |
| Japan |
| Suginami-ku | Tokyo | Japan |
| Kofu | Yamanashi | Japan |
| months |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer Before Primary Immunization | Number | participants |
|
| Simultaneous Vaccination of Pneumococcal Vaccine | Yes = pneumococcal vaccine was administered on the same day at least once in the primary immunization period. | Number | participants |
|
| Simultaneous Vaccination of Diphtheria, Tetanus, Pertussis-Inactivated Polio Vaccine (DPT-IPV) | Yes = DPT-IPV vaccine was administered on the same day at least once in the primary immunization period. | Number | participants |
|
| Simultaneous Vaccination of Rotavirus Vaccine | Yes = rotavirus vaccine was administered on the same day at least once in the primary immunization period. | Number | participants |
|
| Simultaneous Vaccination of Measles-Rubella (MR) Vaccine | Yes = MR vaccine was administered on the same day in the booster vaccination period. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia) | Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia. | FAS included all participants who received at least 1 dose of the study vaccination. | Posted | Number | participants | For 64 Weeks |
|
|
|
| Primary | Number of Participants With Adverse Reactions Related to Local Reactions | Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness). | FAS included all participants who received at least 1 dose of the study vaccination. | Posted | Number | participants | For 64 Weeks |
|
|
|
| Primary | Number of Participants With Adverse Reactions Related to Systemic Reactions | Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness). | FAS included all participants who received at least 1 dose of the study vaccination. | Posted | Number | participants | For 64 Weeks |
|
|
|
| Secondary | Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL | Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity. | FAS, all participants who received at least 1 dose of the study vaccination, with available data. | Posted | Number | 95% Confidence Interval | percentage of participants | For 64 weeks |
|
|
|
| Secondary | Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL | Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity. | FAS, all participants who received at least 1 dose of the study vaccination, with available data. | Posted | Number | 95% Confidence Interval | percentage of participants | For 64 weeks |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Anti-PRP Antibody | Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity. | FAS, all participants who received at least 1 dose of the study vaccination, with available data. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | For 64 weeks |
|
|
|
| 4 |
| 31 |
| 30 |
| 31 |
| Pneumonia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Crying | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Conjunctivitis bacterial | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Exanthema subitum | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Molluscum contagiosum | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
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| Miliaria | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
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| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D007239 | Infections |
| Title | Measurements |
|---|---|
|
| Injection site pain |
|
| Title | Measurements |
|---|
|
| Decreased appetite |
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| Vomiting |
|
| Diarrhoea |
|
| Somnolence |
|
| Insomnia |
|
|
| At 4 Weeks after Booster Vaccination (n=31) |
|
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| At 4 Weeks after Booster Vaccination (n=31) |
|
|
| At 4 Weeks after Booster Vaccination (n=31) |
|