Phase III Study of Intramuscular TAK-816 in Healthy Infants

NCT02074345 | Completed Phase 3 Results

• 3 other identifiers: TAK-816/OCT-002U1111-1153-4027JapicCTI-142454
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.

Conditions

Healthy Volunteers; Haemophilus Influenzae Type b, Prevention

Keywords

Drug therapy; Safety and immunogenicity of Hib vaccine

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL

  For 64 weeks

• Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL

  For 64 weeks

• Geometric Mean Titer (GMT) of Anti-PRP Antibody

  For 64 weeks

Study Arms (1)

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.

Biological: TAK-816

Interventions

TAK-816 BIOLOGICAL

TAK-816 intramuscular injection

TAK-816 0.5 mL

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Japanese infants.
• Male or female infants aged 2-6 months (≥2 and \<7 months) at the time of the first dose of investigational product (excluding hospitalized infants).
• Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
• The legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures.

You may not qualify if:

• Any serious acute illness.
• Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
• History of possible Haemophilus influenzae type b (Hib) infection.
• Previously diagnosed immunodeficiency.
• Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid).
• A history of convulsions.
• Previous administration of another Hib vaccine.
• Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or with any inactivated vaccine during the 6 days before dosing.
• Prior participation in any clinical study or post-marketing clinical study.
• Previously receipt of blood transfusions, gamma globulin preparations (except monoclonal antibody products not containing any components of Hib as antigens), systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive any of these products during the study period.
• Presence of thrombocytopenia or coagulopathy.
• Children considered ineligible for the study for other reasons by the investigator or subinvestigator.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Unknown Facility

Kumagaya-shi, Saitama, Japan

Location

Unknown Facility

Fuchu-shi, Tokyo, Japan

Location

Unknown Facility

Suginami-ku, Tokyo, Japan

Location

Unknown Facility

Kofu, Yamanashi, Japan

Location

Related Publications (1)

• 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.

  PMID: 29685594 DERIVED

MeSH Terms

Conditions

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Senior Manager

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 26, 2016
• Results First Posted: April 26, 2016

Record last verified: 2016-03

Locations

JP (4)