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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52829313

Enrollment

300

Registered

2004-09-22

Start date

2004-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcus/vaccines Infections and Infestations Vaccination

Interventions

Infants will receive 7-valent conjugate pneumococcal vaccine (PCV7) at birth (up to 72 hours - see point mentioned in hypothesis above), 6 and 10 weeks (group 1) or at 6, 10 and 14 weeks (group 2) alo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Clinical safety data in children vaccinated at birth compared to children vaccinated first at 6 weeks of life 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

Measure	Time frame
1. Immunogenicity as measured by anti-capsular IgG ELISA after one or two doses of vaccine, of which one was given at birth 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 3. Functional immune response to first vaccination at birth as measured by prevalence of nasopharyngeal colonisation with S. pneumoniae at 18 and 36 weeks 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 5. Interference with immune response to measles vaccine given at 36 weeks measured by anti-measles antibodies at 37 weeks 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.	—

Measure

Time frame

1. Immunogenicity as measured by anti-capsular IgG ELISA after one or two doses of vaccine, of which one was given at birth 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 3. Functional immune response to first vaccination at birth as measured by prevalence of nasopharyngeal colonisation with S. pneumoniae at 18 and 36 weeks 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 5. Interference with immune response to measles vaccine given at 36 weeks measured by anti-measles antibodies at 37 weeks 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.

—

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026