A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine

A Randomized, Controlled, Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals' 11-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly as a 3-dose Primary Immunization (2-3-4 Month Schedule) Before 6 Months of Age

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169481

Enrollment

689

Registered

2005-09-15

Start date

2004-10-31

Completion date

2005-05-31

Last updated

2017-01-10

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

Conditions

Streptococcal Infections

Brief summary

Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.

Detailed description

Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa

Interventions

BIOLOGICALPneumococcal (vaccine)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

8 Weeks to 16 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.

Exclusion criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. * Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.

Design outcomes

Primary

Measure	Time frame
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination	1 Month after dose 3

Secondary

Measure	Time frame
1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa.	1 Month after dose 3

Countries

Germany

Outcome results

None listed

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