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Trial record 1 of 1 for:    TAK-816/OCT-002
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Phase III Study of Intramuscular TAK-816 in Healthy Infants

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ClinicalTrials.gov Identifier: NCT02074345
Recruitment Status : Completed
First Posted : February 28, 2014
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Healthy Volunteers
Haemophilus Influenzae Type b, Prevention
Intervention Biological: TAK-816
Enrollment 31
Recruitment Details Participants took part in the study at 4 investigative sites in Japan from 13 March 2014 to 25 March 2015.
Pre-assignment Details Participants received open-label TAK-816 0.5 mL vaccinations, 3 initial doses and 1 booster.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) - all participants who received at least 1 dose of the study vaccination.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 31 participants
2.54  (0.587)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
<2 months 0
≥2 - <3 months 22
≥3 - <4 months 8
≥4 - <5 months 1
≥5 months 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
17
  54.8%
Male
14
  45.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 31 participants
31
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 31 participants
58.2  (2.38)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 31 participants
5.62  (0.551)
Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer Before Primary Immunization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
<0.15 µg/mL 4
≥0.15 µg/mL 27
Simultaneous Vaccination of Pneumococcal Vaccine   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
Yes 0
No 31
[1]
Measure Description: Yes = pneumococcal vaccine was administered on the same day at least once in the primary immunization period.
Simultaneous Vaccination of Diphtheria, Tetanus, Pertussis-Inactivated Polio Vaccine (DPT-IPV)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
Yes 0
No 31
[1]
Measure Description: Yes = DPT-IPV vaccine was administered on the same day at least once in the primary immunization period.
Simultaneous Vaccination of Rotavirus Vaccine   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
Yes 27
No 4
[1]
Measure Description: Yes = rotavirus vaccine was administered on the same day at least once in the primary immunization period.
Simultaneous Vaccination of Measles-Rubella (MR) Vaccine   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
Yes 0
No 31
[1]
Measure Description: Yes = MR vaccine was administered on the same day in the booster vaccination period.
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description 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.
Time Frame For 64 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants who received at least 1 dose of the study vaccination.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
31
2.Primary Outcome
Title Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)
Hide Description 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.
Time Frame For 64 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of the study vaccination.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
6
3.Primary Outcome
Title Number of Participants With Adverse Reactions Related to Local Reactions
Hide Description 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).
Time Frame For 64 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of the study vaccination.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Injection site erythema 5
Injection site swelling 1
Injection site induration 1
Injection site pain 0
4.Primary Outcome
Title Number of Participants With Adverse Reactions Related to Systemic Reactions
Hide Description 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).
Time Frame For 64 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of the study vaccination.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Rash 0
Irritability 0
Crying 3
Decreased appetite 0
Vomiting 1
Diarrhoea 5
Somnolence 3
Insomnia 2
5.Secondary Outcome
Title Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
Hide Description 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.
Time Frame For 64 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, all participants who received at least 1 dose of the study vaccination, with available data.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Before Primary Immunization (n=31)
16.1
(5.452 to 33.727)
At 4 Weeks after Primary Immunization (n=30)
100
(88.430 to 100.000)
Before Booster Vaccination (n=31)
77.4
(58.904 to 90.406)
At 4 Weeks after Booster Vaccination (n=31)
100
(88.781 to 100.000)
6.Secondary Outcome
Title Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
Hide Description 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.
Time Frame For 64 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, all participants who received at least 1 dose of the study vaccination, with available data.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Before Primary Immunization (n=31)
87.1
(70.166 to 96.370)
At 4 Weeks after Primary Immunization (n=30)
100
(88.430 to 100.000)
Before Booster Vaccination (n=31)
100
(88.781 to 100.000)
At 4 Weeks after Booster Vaccination (n=31)
100
(88.781 to 100.000)
7.Secondary Outcome
Title Geometric Mean Titer (GMT) of Anti-PRP Antibody
Hide Description 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.
Time Frame For 64 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, all participants who received at least 1 dose of the study vaccination, with available data.
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Before Primary Immunization (n=31)
0.354
(0.2583 to 0.4843)
At 4 Weeks after Primary Immunization (n=30)
19.682
(11.3094 to 34.2544)
Before Booster Vaccination (n=31)
3.087
(2.0482 to 4.6518)
At 4 Weeks after Booster Vaccination (n=31)
51.334
(31.0689 to 84.8159)
Time Frame For 64 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title TAK-816 0.5 mL
Hide Arm/Group Description 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.
All-Cause Mortality
TAK-816 0.5 mL
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAK-816 0.5 mL
Affected / at Risk (%)
Total   4/31 (12.90%) 
Gastrointestinal disorders   
Inguinal hernia  1  1/31 (3.23%) 
Infections and infestations   
Pneumonia  1  2/31 (6.45%) 
Pneumonia bacterial  1  1/31 (3.23%) 
Respiratory syncytial virus bronchiolitis  1  1/31 (3.23%) 
Respiratory syncytial virus infection  1  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAK-816 0.5 mL
Affected / at Risk (%)
Total   30/31 (96.77%) 
Gastrointestinal disorders   
Diarrhoea  1  11/31 (35.48%) 
Vomiting  1  2/31 (6.45%) 
General disorders   
Pyrexia  1  14/31 (45.16%) 
Injection site erythema  1  5/31 (16.13%) 
Crying  1  4/31 (12.90%) 
Injection site swelling  1  2/31 (6.45%) 
Infections and infestations   
Nasopharyngitis  1  15/31 (48.39%) 
Gastroenteritis  1  4/31 (12.90%) 
Bronchitis  1  3/31 (9.68%) 
Conjunctivitis bacterial  1  3/31 (9.68%) 
Exanthema subitum  1  2/31 (6.45%) 
Molluscum contagiosum  1  2/31 (6.45%) 
Nervous system disorders   
Somnolence  1  3/31 (9.68%) 
Psychiatric disorders   
Insomnia  1  4/31 (12.90%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation  1  5/31 (16.13%) 
Skin and subcutaneous tissue disorders   
Eczema  1  6/31 (19.35%) 
Dermatitis diaper  1  3/31 (9.68%) 
Miliaria  1  3/31 (9.68%) 
Eczema asteatotic  1  2/31 (6.45%) 
Rash  1  2/31 (6.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 18.0
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.
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.
Results Point of Contact
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02074345     History of Changes
Other Study ID Numbers: TAK-816/OCT-002
U1111-1153-4027 ( Registry Identifier: UTN )
JapicCTI-142454 ( Registry Identifier: JapicCTI )
First Submitted: February 26, 2014
First Posted: February 28, 2014
Results First Submitted: March 24, 2016
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016