Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Streptococcal

Treatments: Biological: Synflorix; Biological: Infanrix IPV/Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345358

107058

Details and patient eligibility

About

The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules:

< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.

Full description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Enrollment: 600 patients

Sex: All

Ages: 9 weeks to 60 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female between, and including

  • 9-12 weeks of age at the time of first vaccination for the <6 Mo group.
  • 7-11 months of age at the time of first vaccination for the 7-11 Mo group.
  • 12-23 months of age at the time of first vaccination for the 12-23 Mo group.
  • 24 months to 5 years at the time of first vaccination for the >= 24 Mo group.

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

• Written informed consent obtained from the parent or guardian of the subject.

• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

• Born after a gestation period between 36 and 42 weeks.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).
• Previous vaccination against S. pneumoniae.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.
• Acute disease at the time of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Synflorix <6M Group

Active Comparator group

Description:

This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Treatment:

Biological: Infanrix IPV/Hib

Biological: Synflorix

Synflorix 7-11M Group

Experimental group

Description:

This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Treatment:

Biological: Synflorix

Synflorix 12-23M Group

Experimental group

Description:

This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Treatment:

Biological: Synflorix

Synflorix >=24M Group

Experimental group

Description:

This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Treatment:

Biological: Synflorix