Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule

• Register: ClinicalTrials.gov
• Last refreshed on: 26 November 2012
• Main ID: NCT00307034
• Date of registration: 24/03/2006
• Primary sponsor: GlaxoSmithKline
• Public title: Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
• Scientific title: An Open, Randomized, Phase IIIa Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly According to a 2-4-11 Months Vaccination Schedule
• Date of first enrolment: January 2006
• Target sample size: 351
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00307034
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Denmark, Norway, Slovakia, Sweden

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

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

- A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the
time of the first vaccination.

- 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 of 36 to 42 weeks.

Exclusion criteria:

- Use of any investigational or non-registered drug or vaccine other than the study
vaccine(s) 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 30 days before the first dose of vaccine(s) and
ending 30 days after the last dose, with exception of BCG vaccination which can be
given after the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule)
blood sampling and a minimum of 30 days before the pre-booster dose blood sampling.

- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
Haemophilus influenzae type b, and/or S. pneumoniae.

- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio,
Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines.

- History of any neurologic disorders or seizures.

- Acute disease at the time of enrolment.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth.

- 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 study period.



Age minimum: 8 Weeks
Age maximum: 16 Weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Pneumococcal Infections

Intervention(s)

Biological: GSK Biologicals' 10-valent pneumococcal conjugate vaccine.

Biological: Infanrix hexa.

Biological: Infanrix-IPV/Hib.

Primary Outcome(s)

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL. [Time Frame: 1 month post-dose 2 (2-4-11 months of age schedule) of GSK Biologicals' 10-valent pneumococcal conjugate vaccine.]

Secondary Outcome(s)

Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-pertussis, anti-HBs antibody concentrations and anti-polio type 1, 2 and 3 titres. [Time Frame: 1 month post-dose 2, prior to and 1 month post-booster dose of DTPa-combined vaccine.]

Concentrations of antibodies against protein D. [Time Frame: 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule), prior to and 1 month post-booster dose of pneumococcal conjugate vaccine.]

Concentrations of antibodies against vaccine pneumococcal serotypes. [Time Frame: 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule), prior to and 1 month post-booster dose of pneumococcal conjugate vaccine.]

Occurrence of serious adverse events. [Time Frame: Throughout the whole study period.]

Occurrence of solicited general symptoms [Time Frame: Within 4 days after each vaccination.]

Occurrence of solicited local symptoms. [Time Frame: Within 4 days after each vaccination.]

Occurrence of unsolicited adverse events. [Time Frame: Within 31 days after each vaccination.]

Opsonophagocytic activity against vaccine pneumococcal serotypes. [Time Frame: 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule), prior to and 1 month post-booster dose of pneumococcal conjugate vaccine.]

Secondary ID(s)

105539

Source(s) of Monetary Support

Please refer to primary and secondary sponsors