NCT00625677

Brief Summary

The purpose of this study is: To assess whether there are differences in antibody persistence eight months post primary (pre-booster) or in responses to the booster with regard to the Meningococcal C Conjugate (MCC) vaccine given in infancy. To examine levels of diphtheria and tetanus antibody pre- and post-booster, with regard to the carrier proteins contained in the conjugate vaccines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2008

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

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

February 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 22, 2019

Status Verified

September 1, 2010

Enrollment Period

2.1 years

First QC Date

February 19, 2008

Last Update Submit

March 20, 2019

Conditions

Meningococcal InfectionsPneumococcal Infections

Keywords

meningococcal serogroup C vaccinereduced dosemeningococcal serogroup C conjugate vaccinepneumococcal conjugate vaccine

Study Arms (2)

1

EXPERIMENTAL

Pediacel - 2,3,4 months Prevenar - 2,4 months Menjugate - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months Blood collected - 4,5,12,13 months

Biological: Menjugate (Meningococcal C conjugate vaccine)

2

EXPERIMENTAL

Pediacel - 2,3,4 months Prevenar - 2,4 months Neis-vacC - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months Blood collected - 4,5,12,13 months

Biological: NeisVacC (Meningococcal C conjugate vaccine)

Interventions

NeisVacC (Meningococcal C conjugate vaccine)BIOLOGICAL

Dosage

Also known as: Meningococcal C conjugate vaccine, Neis-vacC
2
Menjugate (Meningococcal C conjugate vaccine)BIOLOGICAL

Dosage

Also known as: Meningococcal C conjugate vaccine, Menjugate
1

Eligibility Criteria

Age7 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
  • Written informed consent obtained from the parent or legal guardian of the infant
  • Infant aged no less than 7 weeks exactly, and no more than 11 weeks 6 days

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Protection Agency

Gloucester, United Kingdom

Location

Health Protection Agency

London, United Kingdom

Location

Related Publications (3)

  • Miller E, Andrews N, Waight P, Findlow H, Ashton L, England A, Stanford E, Matheson M, Southern J, Sheasby E, Goldblatt D, Borrow R. Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps, and rubella vaccine at 12 months of age. Clin Vaccine Immunol. 2011 Mar;18(3):367-72. doi: 10.1128/CVI.00516-10. Epub 2010 Dec 29.

    PMID: 21191076RESULT

  • Borrow R, Andrews N, Findlow H, Waight P, Southern J, Crowley-Luke A, Stapley L, England A, Findlow J, Miller E. Kinetics of antibody persistence following administration of a combination meningococcal serogroup C and haemophilus influenzae type b conjugate vaccine in healthy infants in the United Kingdom primed with a monovalent meningococcal serogroup C vaccine. Clin Vaccine Immunol. 2010 Jan;17(1):154-9. doi: 10.1128/CVI.00384-09. Epub 2009 Nov 11.

    PMID: 19906895RESULT

  • Southern J, Borrow R, Andrews N, Morris R, Waight P, Hudson M, Balmer P, Findlow H, Findlow J, Miller E. Immunogenicity of a reduced schedule of meningococcal group C conjugate vaccine given concomitantly with the Prevenar and Pediacel vaccines in healthy infants in the United Kingdom. Clin Vaccine Immunol. 2009 Feb;16(2):194-9. doi: 10.1128/CVI.00420-08. Epub 2008 Dec 17.

    PMID: 19091990RESULT

MeSH Terms

Conditions

Meningococcal InfectionsPneumococcal Infections

Interventions

serogroup C meningococcal conjugate vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsStreptococcal InfectionsGram-Positive Bacterial Infections

Study Officials

  • Elizabeth Miller, BSc MBBS FFPHM FRCPath

    Public Health England

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 22, 2019

Record last verified: 2010-09

Locations

GB(2)