Clinical trial

Study of the Safety and Immune Response of a Meningococcal Vaccine Administered…

NCT00262002 · Novartis Vaccines, Industry · Completed

Key facts

NCT number NCT00262002
Title Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
Official title A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of…
Lead sponsor Novartis Vaccines, Industry
Collaborators Novartis Industry
Status Completed
Phase Phase 2
Study type Interventional
Conditions Prevention of Meningococcal Disease
Intervention type Biological
Interventions MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation), MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation), MenACWY PS (MenACWY-CRM, polysaccharide vaccine), HBV (Hepatitis B vaccine), Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14 and 11 more
Enrollment 601
Start date Sep 1, 2004
Primary completion Jul 1, 2005
Completion Oct 1, 2006
First posted Dec 6, 2005
Last update posted Jun 18, 2014
Countries Canada, United Kingdom

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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