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Can we Reduce the Number of Vaccine Injections for Children?

NCT01129518 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2015-11-09

No results posted yet for this study

Summary

This open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other concurrent routine vaccinations. All groups will also be further divided into 2 groups to receive their routine vaccines in either consistent or alternating limbs to assess the immune response to the concurrent infant routine immunisations administered in consistent versus alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24 months of age.

Conditions

  • Invasive Meningococcal Disease

Interventions

BIOLOGICAL

Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine

In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly. Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two.

BIOLOGICAL

Routine schedule immunisations except monovalent MenC vaccine

Routine schedule immunisations will be given according to NHS guidelines.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-07-31

Countries

  • United Kingdom

Study Locations

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Entities

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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 NCT01129518 on ClinicalTrials.gov