Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules

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

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-12

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.

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Detailed Description

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Conditions

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Immunogenicity, Vaccine Immunologic Memory

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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3+1

Healthy infants will receive 4 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4,6 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.

13-valent pneumococcal conjugate vaccine (PCV13)

Intervention Type BIOLOGICAL

Vaccination with PCV13

3+0

Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 6 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.

13-valent pneumococcal conjugate vaccine (PCV13)

Intervention Type BIOLOGICAL

Vaccination with PCV13

2+1

Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.

13-valent pneumococcal conjugate vaccine (PCV13)

Intervention Type BIOLOGICAL

Vaccination with PCV13

Interventions

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13-valent pneumococcal conjugate vaccine (PCV13)

Vaccination with PCV13

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevenar13

Eligibility Criteria

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Inclusion Criteria

* 2-15 months of age

Exclusion Criteria

* previously recorded allergy to PCV
* intravenous immunoglobulin (IVIG) given within the previous 6 months
* primary or secondary immunodeficiency
* any chronic medical condition

Minimum Eligible Age

2 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes