NCT00581035

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants

Trial Health

100
On Track

Trial Health Score

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

Enrollment
712

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Jan 2006

Typical duration for phase_4 healthy

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
Last Updated

December 27, 2007

Status Verified

December 1, 2007

First QC Date

December 21, 2007

Last Update Submit

December 26, 2007

Conditions

Healthy

Keywords

Meningococcal diseasepneumococcal diseasemeningitis

Outcome Measures

Primary Outcomes (1)

  • The pneumococcal and meningococcal responses achieved after the infant series

    7 months

Secondary Outcomes (1)

  • The pneumococcal and meningococcal responses achieved after the toddler dose

    13 months

Study Arms (3)

1

EXPERIMENTAL

Prevenar and Meningitec

Biological: Prevenar and Meningitec

2

EXPERIMENTAL

Prevenar

Biological: Prevenar

3

EXPERIMENTAL

Meningitec

Biological: Meningitec

Interventions

Prevenar and MeningitecBIOLOGICAL

1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months

1
PrevenarBIOLOGICAL

1 dose at 2,3.5,6 and 12 months

2
MeningitecBIOLOGICAL

1 dose at 2,6 and 12 months

3

Eligibility Criteria

Age42 Days - 63 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants aged 6 to 9 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningococcal InfectionsPneumococcal InfectionsMeningitis

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsNeuroinflammatory DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

January 1, 2006

Study Completion

May 1, 2007

Last Updated

December 27, 2007

Record last verified: 2007-12