eonatal immunisation with pneumoccal conjugate vaccines: immunogenicity and the generation memory (Kenya)

Completed

• Conditions: Pneumococcus/vaccines; Infections and Infestations; Vaccination

• Registration Number: ISRCTN52829313
• Lead Sponsor: Kenya Medical Research Institute (Kenya)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Healthy infants born to mothers tested human immunodeficiency virus (HIV) negative in the voluntary counselling and testing service
2. Not known to have congenital immune deficiency
3. Birth weight greater than 2500 g
4. Informed consent

Exclusion Criteria

1. Infants requiring ongoing hospitalisation after birth
2. Suspected immune deficiency
3. Participation in another clinical trial

Any child who suffers a serious adverse event directly attributable to pneumococcal vaccination will be excluded from continued participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical safety data in children vaccinated at birth compared to children vaccinated first at 6 weeks of life<br>2. Immunogenicity as measured by anti-capsular Immunoglobulin G (IgG) Enzyme-Linked Immuno-Sorbent Assay (ELISA) to serotypes in the vaccine, measured after a complete primary course at 18 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Immunogenicity as measured by anti-capsular IgG ELISA after one or two doses of vaccine, of which one was given at birth<br>2. Immunological memory measured as IgG response to a booster vaccine dose (either PCV or 1/5th dose pneumococcal polysaccharide vaccine with a 50% probability of each) at 36 weeks<br>3. Functional immune response to first vaccination at birth as measured by prevalence of nasopharyngeal colonisation with S. pneumoniae at 18 and 36 weeks<br>4. Interference with immune response to diphtheria and tetanus attributable to vaccination with PCV at birth as measured by diphtheria and tetanus antibody concentration at 18 weeks<br>5. Interference with immune response to measles vaccine given at 36 weeks measured by anti-measles antibodies at 37 weeks<br>6. Effect of (maternal) pre-existing pneumococcal, diphtheria and tetanus antibody levels at birth on immune response to the primary course of PCV, and Diphtheria Pertussis Tetanus (DPT) vaccine.