Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines (sched1)

Public Health England

Status and phase: Completed; Phase 4

Conditions: Meningococcal Infections; Pneumococcal Infections

Treatments: Biological: Men C conjugate; Biological: menjugate; Biological: Men C Conjugate; Biological: Men C conjugate vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00197808

sched1

Details and patient eligibility

About

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.

Enrollment: 392 patients

Sex: All

Ages: 7 to 11 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 6 patient groups

Vaccine schedule 1

Experimental group

Description:

Menjugate vaccine at 2 and 3 months

Treatment:

Biological: menjugate

Vaccine schedule 2

Experimental group

Description:

Menjugate vaccine at 2 and 4 months

Treatment:

Biological: Men C conjugate vaccine

vaccine schedule3

Experimental group

Description:

Neissvacc at 2 and 3 months

Treatment:

Biological: Men C conjugate

Biological: Men C conjugate

Biological: Men C conjugate

vaccine schedule 4

Experimental group

Description:

Neissvacc at 2 and 4 months

Treatment:

Biological: Men C Conjugate

Vaccine schedule 5

Experimental group

Description:

Meningitec at 2 and 3 months

Treatment:

Biological: Men C conjugate

Biological: Men C conjugate

Biological: Men C conjugate

Vaccine schedule 6

Experimental group

Description:

Meningitec at 2 and 4 months

Treatment:

Biological: Men C conjugate

Biological: Men C conjugate

Biological: Men C conjugate