Study of TAK-816 in Healthy Infants

Immunization Clinical Trial

Official title:

A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379846
• Other study ID #: TAK-816/CCT-001
• Secondary ID: JapicCTI-111516U
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2011
• Last updated: March 4, 2013
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when administered to healthy Japanese infants as multiple subcutaneous doses.

Description:

Haemophilus Influenzae type b (Hib) is one of the major causes of infectious meningitis in children, and can also cause sepsis, cellulitis, arthritis, epiglottitis, pneumonia and myelitis.

TAK-816 is a conjugated Hib vaccine being tested in healthy infants aged 3-6 months at the time of the first dose.

The objective of this study is to evaluate the efficacy (immunogenicity) and safety of TAK-816 (10 ϻg/0.5 mL) in comparison with ActHIB (Haemophilus b Conjugate Vaccine) as a control.

In addition, the efficacy (immunogenicity) and safety of Absorbed Diphtheria-Purified Pertussis-Tetanus Combined (DPT-TAKEDA) vaccine when TAK-816 and DPT vaccine are administered concomitantly will also be investigated.

For the Primary Immunization Phase of this study: three doses of TAK-816 or ActHIB 10 µg/0.5 mL and DPT-TAKEDA 0.5 mL will be administered at 4-week intervals over 8 weeks (Visit 1, 2, 3). At4 weeks after the third dose, a follow-up observation and evaluation will be made (Visit 4).

For the Booster Vaccination Phase of this study: a single dose of TAK-816 or ActHIB 10 µg/0.5 mL and DPT-TAKEDA 0.5 mL will be given at 52 weeks after the third dose (Visit 5). At 4 weeks after the fourth dose, a follow-up observation and evaluation will be made (Visit 6).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 6 Months

Eligibility

Inclusion Criteria:

1. Male or female infants aged =3 and <7 months (excluding hospitalized infants).

2. Infants whose legal acceptable representatives have given informed consent to the study prior to enrollment.

3. Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.

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. History of possible pertussis, diphtheria or tetanus infection.

5. Previously diagnosed immunodeficiency.

6. A documented history of anaphylaxis to any ingredient of the investigational products (TAK-816, ActHIB or DPT-TAKEDA).

7. A history of convulsions.

8. Previous administration of another Hib vaccine.

9. Previous administration of any other vaccine containing any of the components of polio, diphtheria, pertussis, or tetanus.

10. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immunization

Intervention

Biological:
• TAK-816+ DPT-TAKEDA
TAK-816 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.
• ActHIB+ DPT-TAKEDA
ActHIB 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer =1 ?g/mL		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer =0.15 ?g/mL		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-PRP geometric mean titers (GMT)		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-PRP titer =1 ?g/mL		4 weeks after the single booster dose. (Visit 6)	No
Secondary	Proportion of participants with an anti-PRP titer =0.15 ?g/mL		4 weeks after the single booster dose. (Visit 6)	No
Secondary	Proportion of participants with an anti-PRP GMT		4 weeks after the single booster dose. (Visit 6)	No
Secondary	Proportion of participants with an anti-diphtheria toxoid titer =0.1 IU/mL		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-diphtheria toxoid GMT		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-diphtheria toxoid titer =0.1 IU/mL		4 weeks after the single booster dose (Visit 6)	No
Secondary	Proportion of participants with an anti-diphtheria toxoid GMT		4 weeks after the single booster dose (Visit 6)	No
Secondary	Proportion of participants with an anti-pertussis toxin (PT) titer =10 EU/mL		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-PT GMT		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-PT titer =10 EU/mL		4 weeks after the single booster dose (Visit 6)	No
Secondary	Proportion of participants with an anti-PT GMT		4 weeks after the single booster dose (Visit 6)	No
Secondary	Proportion of participants with an anti-filamentous hemagglutinin (FHA) titer =10 EU/mL		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-FHA GMT		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-FHA titer =10 EU/mL		4 weeks after the single booster dose (Visit 6)	No
Secondary	Proportion of participants with an anti-FHA GMT		4 weeks after the single booster dose (Visit 6)	No
Secondary	Proportion of participants with an anti-tetanus toxoid titer =0.01 IU/mL		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-tetanus toxoid GMT		4 weeks after the third dose (Visit 4)	No
Secondary	Proportion of participants with an anti-tetanus toxoid titer =0.01 IU/mL		4 weeks after the single booster dose (Visit 6)	No
Secondary	Proportion of participants with an anti-tetanus toxoid GMT		4 weeks after the single booster dose (Visit 6)	No