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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 4 investigative sites in Japan from 13 March 2014 to 25 March 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants received open-label TAK-816 0.5 mL vaccinations, 3 initial doses and 1 booster.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    TAK-816 0.5 mL
STARTED   31 
COMPLETED   31 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) - all participants who received at least 1 dose of the study vaccination.

Reporting Groups
  Description
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.

Baseline Measures
   TAK-816 0.5 mL 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Months]
Mean (Standard Deviation)
 2.54  (0.587) 
Age, Customized 
[Units: Participants]
 
<2 months   0 
≥2 - <3 months   22 
≥3 - <4 months   8 
≥4 - <5 months   1 
≥5 months   0 
Gender 
[Units: Participants]
 
Female   17 
Male   14 
Region of Enrollment 
[Units: Participants]
 
Japan   31 
Height 
[Units: Cm]
Mean (Standard Deviation)
 58.2  (2.38) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 5.62  (0.551) 
Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer Before Primary Immunization 
[Units: Participants]
 
<0.15 µg/mL   4 
≥0.15 µg/mL   27 
Simultaneous Vaccination of Pneumococcal Vaccine [1] 
[Units: Participants]
 
Yes   0 
No   31 
[1] 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] 
[Units: Participants]
 
Yes   0 
No   31 
[1] Yes = DPT-IPV vaccine was administered on the same day at least once in the primary immunization period.
Simultaneous Vaccination of Rotavirus Vaccine [1] 
[Units: Participants]
 
Yes   27 
No   4 
[1] 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] 
[Units: Participants]
 
Yes   0 
No   31 
[1] Yes = MR vaccine was administered on the same day in the booster vaccination period.


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: For 64 Weeks ]

2.  Primary:   Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)   [ Time Frame: For 64 Weeks ]

3.  Primary:   Number of Participants With Adverse Reactions Related to Local Reactions   [ Time Frame: For 64 Weeks ]

4.  Primary:   Number of Participants With Adverse Reactions Related to Systemic Reactions   [ Time Frame: For 64 Weeks ]

5.  Secondary:   Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL   [ Time Frame: For 64 weeks ]

6.  Secondary:   Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL   [ Time Frame: For 64 weeks ]

7.  Secondary:   Geometric Mean Titer (GMT) of Anti-PRP Antibody   [ Time Frame: For 64 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Clinical Science
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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