Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488

A Phase II, Multicentre Booster Study to Evaluate Booster Vaccination With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or to Evaluate the Immune Memory Following the Administration of a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children, Previously Vaccinated in Infancy in the Primary Study 11PN-PD-DIT-002 (103488)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00307567

Enrollment

689

Registered

2006-03-28

Start date

2005-11-30

Completion date

2006-03-31

Last updated

2016-09-23

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

Conditions

Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis, Tetanus

Brief summary

Booster and immune memory study

Detailed description

Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib

Interventions

BIOLOGICALPneumococcal (vaccine)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Months to 18 Months

Healthy volunteers

Yes

Inclusion criteria

Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study

Design outcomes

Primary

Measure	Time frame
1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,	—

Secondary

Measure	Time frame
Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL	—
Ab concentrations to protein D & seropositivity (S+) status	—
Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*	—
Occurrence of: solicited local,general symptoms within 4 d	—
Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster	—
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine	—

Countries

Germany

Outcome results

None listed

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