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Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

NCT00806195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7744

Last updated 2013-07-09

Study results available
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Summary

The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

Conditions

Interventions

BIOLOGICAL

MenACWY-CRM197

Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.

BIOLOGICAL

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.

BIOLOGICAL

Hib (Haemophilus influenza b) Vaccine

Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.

BIOLOGICAL

IPV (Inactivated Polio Vaccine) Vaccine

Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.

BIOLOGICAL

Pneumococcal conjugate Vaccine

Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.

BIOLOGICAL

MMR (Measles, Mumps, and Rubella) Vaccine

One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.

BIOLOGICAL

Varicella Vaccine

One vaccination of Varicella vaccine was administered at 12 months of age.

BIOLOGICAL

Hepatitis A Virus

One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-03-31
Completion
2011-11-30

Countries

  • United States
  • China
  • Costa Rica
  • Guatemala
  • Panama
  • Peru

Study Locations

More Related Trials

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 NCT00806195 on ClinicalTrials.gov