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Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

NCT00317187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2018-08-15

No results posted yet for this study

Summary

The purpose of this study is to compare the reactogenicity \& safety of Tritanrixâ„¢-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrixâ„¢-HepB/Hiberixâ„¢.

Conditions

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

Interventions

BIOLOGICAL

Tritanrix-HepB/Meningitec conjugate vaccine

The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection

BIOLOGICAL

Tritanrix/Hiberix vaccine

The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Model
PARALLEL

Eligibility

Min Age
56 Days
Max Age
83 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-08
Primary Completion
2005-01-16
Completion
2005-01-16

Countries

  • Thailand

Study Locations

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Entities

Diseases
Companies

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 NCT00317187 on ClinicalTrials.gov