MedTrace Logo

Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

NCT00313911 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2133

Last updated 2014-04-21

Study results available
· View outcomes & findings →

Summary

To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.

To evaluate the overall safety in terms of:

Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.

Immunogenicity:

To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Haemophilus Influenzae Type b
  • Hepatitis B

Interventions

BIOLOGICAL

DTaP-IPV-HB-PRP~T

0.5 mL, Intramuscular (IM)

BIOLOGICAL

Tritanrix-HepB/Hib

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Days
Max Age
71 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-01-31
Completion
2008-02-29

Countries

  • Mexico
  • Peru

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 NCT00313911 on ClinicalTrials.gov