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DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

NCT02274285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary objective:

* To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens).

Secondary objectives:

* To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B).
* To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B).
* To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)

Conditions

  • Tetanus
  • Diphtheria
  • Pertussis
  • Poliomyelitis
  • Bacterial Meningitis

Interventions

BIOLOGICAL

DTaP-IPV/Hib Combined vaccine

0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart

BIOLOGICAL

DTaP-IPV vaccine and Hib vaccine

0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart

BIOLOGICAL

DTaP-IPV/Hib Combined vaccine

0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
68 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-05-28
Completion
2016-05-28

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02274285 on ClinicalTrials.gov