MedTrace Logo

NeisVac-C Single Prime Study in Infants

NCT01218451 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 956

Last updated 2015-05-21

No results posted yet for this study

Summary

The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.

Conditions

  • Neisseria Meningitidis

Interventions

BIOLOGICAL

Meningococcal group C polysaccharide conjugate vaccine

0.5 mL dose, subcutaneous administration in right anterolateral thigh

BIOLOGICAL

Pneumococcal 13-valent conjugate vaccine

0.5 mL dose, subcutaneous administration in right anterolateral thigh

BIOLOGICAL

Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine

0.5 mL dose, subcutaneous administration in right anterolateral thigh

Sponsors & Collaborators

Principal Investigators

  • Baxter BioScience Investigator, MD · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
11 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-01-31
Completion
2012-06-30

Countries

  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT01218451 on ClinicalTrials.gov