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A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject

NCT01917357 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2014-07-15

No results posted yet for this study

Summary

This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.

Conditions

  • Diphtheria
  • Pertussis
  • Tetanus
  • Hepatitis B
  • Haemophilus Infections

Interventions

BIOLOGICAL

Quinvaxem in Uniject

BIOLOGICAL

Quinvaxem in single dose vials

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Maria RZ Capeding, MD · Research Institute for Tropical Medicine (RITM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
64 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Diseases

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 NCT01917357 on ClinicalTrials.gov