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

Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333450

Enrollment

120

Registered

2006-06-05

Start date

2006-08-31

Completion date

2006-12-31

Last updated

2016-10-07

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

Conditions

Infections, Streptococcal

Brief summary

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

Detailed description

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

Interventions

BIOLOGICALPneumococcal vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Months to 14 Months

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Antibody concentrations against pneumococcal serotypes 1 month post-booster	—

Secondary

Measure	Time frame
Immunogenicity pre and post-booster and safety (follow up of SAEs)	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026