Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines

NCT ID: NCT00197808

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-01-31

Brief Summary

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The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.

Detailed Description

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Conditions

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Pneumococcal Infections Meningococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaccine schedule 1

Menjugate vaccine at 2 and 3 months

Group Type EXPERIMENTAL

menjugate

Intervention Type BIOLOGICAL

men C conjugate vaccine

Vaccine schedule 2

Menjugate vaccine at 2 and 4 months

Group Type EXPERIMENTAL

Men C conjugate vaccine

Intervention Type BIOLOGICAL

men C conjugate vaccine

vaccine schedule3

Neissvacc at 2 and 3 months

Group Type EXPERIMENTAL

Men C conjugate

Intervention Type BIOLOGICAL

men C conjugate vaccine

vaccine schedule 4

Neissvacc at 2 and 4 months

Group Type EXPERIMENTAL

Men C Conjugate

Intervention Type BIOLOGICAL

men C conjugate vaccine

Vaccine schedule 5

Meningitec at 2 and 3 months

Group Type EXPERIMENTAL

Men C conjugate

Intervention Type BIOLOGICAL

men C conjugate vaccine

Vaccine schedule 6

Meningitec at 2 and 4 months

Group Type EXPERIMENTAL

Men C conjugate

Intervention Type BIOLOGICAL

men C conjugate vaccine

Interventions

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menjugate

men C conjugate vaccine

Intervention Type BIOLOGICAL

Men C conjugate vaccine

men C conjugate vaccine

Intervention Type BIOLOGICAL

Men C conjugate

men C conjugate vaccine

Intervention Type BIOLOGICAL

Men C Conjugate

men C conjugate vaccine

Intervention Type BIOLOGICAL

Men C conjugate

men C conjugate vaccine

Intervention Type BIOLOGICAL

Men C conjugate

men C conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained from parent or legal guardian of infant
* Age 7-11 weeks at first dose

Exclusion Criteria

* Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
* \< 7 weeks or \> 11 weeks at first dose
Minimum Eligible Age

7 Weeks

Maximum Eligible Age

11 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health England

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Coates, PhD

Role: STUDY_CHAIR

Public Health England

Locations

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Hertfordshire Primary Care Trusts

Welwyn Garden City, Hertfordshire, United Kingdom

Site Status

Gloucestershire Primary Care Trusts

Gloucester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7.

Reference Type RESULT
PMID: 16567982 (View on PubMed)

Goldblatt D, Southern J, Ashton L, Andrews N, Woodgate S, Burbidge P, Waight P, Miller E. Immunogenicity of a reduced schedule of pneumococcal conjugate vaccine in healthy infants and correlates of protection for serotype 6B in the United Kingdom. Pediatr Infect Dis J. 2010 May;29(5):401-5. doi: 10.1097/INF.0b013e3181c67f04.

Reference Type DERIVED
PMID: 20010312 (View on PubMed)

Related Links

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Other Identifiers

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sched1

Identifier Type: -

Identifier Source: org_study_id

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