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Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Infections, Streptococcal

Treatments

Biological: Pneumococcal vaccine

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

Full description

2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Sex

All

Ages

11 to 14 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

  • healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.

Exclusion:

  • children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
  • children having received any additional pneumococcal vaccine than in the primary study;
  • children with any disease that affect the immune system and history of seizures and/or allergic disease.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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