Phase III Study of Intramuscular TAK-816 in Healthy Infants

Phase 3

Completed

• Conditions: Healthy Volunteers; Haemophilus Influenzae Type b, Prevention
• Interventions: Biological: TAK-816

• Registration Number: NCT02074345
• Lead Sponsor: Takeda

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Study Start: 2014-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-03
• Results First Submitted: 2016-03-24
• Results First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Results First Posted: 2016-04-26
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Healthy Japanese infants.
2. 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).
3. Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
4. The legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures.

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Exclusion Criteria

1. Any serious acute illness.
2. Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
3. History of possible Haemophilus influenzae type b (Hib) infection.
4. Previously diagnosed immunodeficiency.
5. Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid).
6. A history of convulsions.
7. Previous administration of another Hib vaccine.
8. 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.
9. Prior participation in any clinical study or post-marketing clinical study.
10. 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.
11. Presence of thrombocytopenia or coagulopathy.
12. Children considered ineligible for the study for other reasons by the investigator or subinvestigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAK-816 0.5 mL	TAK-816	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	For 64 Weeks	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.
Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)	For 64 Weeks	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.
Number of Participants With Adverse Reactions Related to Local Reactions	For 64 Weeks	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).
Number of Participants With Adverse Reactions Related to Systemic Reactions	For 64 Weeks	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL	For 64 weeks	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.
Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL	For 64 weeks	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.
Geometric Mean Titer (GMT) of Anti-PRP Antibody	For 64 weeks	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.