Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Streptococcal

Treatments: Biological: Synflorix; Biological: Infanrix hexa; Biological: Prevenar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00370396

2006-001628-38 (EudraCT Number)

107046

Details and patient eligibility

About

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.

Enrollment: 1,200 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 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 vaccination, or planned use during the entire study period (active phase and safety follow-up).
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2.
• Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of study 105553. Children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.

Trial design

1,200 participants in 3 patient groups

Synflorix-Synflorix Group

Experimental group

Description:

This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.

Treatment:

Biological: Infanrix hexa

Biological: Synflorix

Prevenar-Prevenar Group

Active Comparator group

Description:

This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.

Treatment:

Biological: Prevenar

Biological: Infanrix hexa

Prevenar-Synflorix Group

Experimental group

Description:

This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid.

Treatment:

Biological: Infanrix hexa

Biological: Synflorix