NCT00314041

Brief Summary

Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines. Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 1997

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1998

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

April 10, 2006

Last Update Submit

February 20, 2013

Conditions

Meningitis, Meningococcal

Keywords

InfantConjugate vaccineMeningococcalAntibodyImmune memoryHealthMeningococcal Vaccines

Outcome Measures

Primary Outcomes (1)

  • Antibody responses to MnCC and concomitant vaccines

Secondary Outcomes (1)

  • Safety and reactogenicity

Interventions

Meningococcal CBIOLOGICAL
DTP/HibBIOLOGICAL

Eligibility Criteria

Age7 Weeks - 10 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants 7-10 weeks of age eligible to receive routine immunization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningitis, Meningococcal

Interventions

diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For United Kingdom, ukmedinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

June 1, 1997

Primary Completion

April 1, 1998

Study Completion

April 1, 1998

Last Updated

February 21, 2013

Record last verified: 2013-02