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Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

NCT00322335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2016-10-20

Study results available
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Summary

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives \& outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050).

The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

Haemophilus influenzae type b- and meningococcal (vaccine)

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

BIOLOGICAL

Infanrix™ penta

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

BIOLOGICAL

Infanrix™ hexa

Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

BIOLOGICAL

Engerix-B

Intramuscular injection into the thigh as a birth dose

BIOLOGICAL

NeisVac-C™

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

BIOLOGICAL

Infanrix™ IPV/HIB

Intramuscular injection into the thigh as primary vaccination at 4 months of age

BIOLOGICAL

Meningitec™

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
31 Months
Max Age
33 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-07-31
Completion
2010-09-30

Countries

  • Spain

Study Locations

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Entities

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 NCT00322335 on ClinicalTrials.gov