Clinical trial NCT00307034: Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Primary vaccination
Pneumococcal disease
Safety
Booster vaccination
Immunogenicity
Pneumococcal vaccine
Dose comparison
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 351
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)

Detailed description: Total anticipated: 300 subjects (150/group). 2-dose group - 10-valent pneumococcal vaccine + DTPa combined vaccine (2, 4, 11 months); Comparator group - 10-valent pneumococcal vaccine (2, 3, 4, 11 months) + DTPa combined vaccine (2, 4, 11 months). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Pneumococcal Serotypes
timeFrame: One month post-dose 2 (Month 3) administration of Synflorix™ vaccine
Secondary outcomes:
measure: Number of Seroprotected Subjects Against Pneumococcal Serotypes
timeFrame: One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
measure: Antibody Concentrations Against Pneumococcal Serotypes
timeFrame: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
measure: Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
timeFrame: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
measure: Antibody Concentrations Against Protein D (Anti-PD)
timeFrame: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
measure: Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids
timeFrame: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
measure: Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)
timeFrame: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine
measure: Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
timeFrame: One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine
measure: Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)
timeFrame: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
measure: Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)
timeFrame: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
measure: Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies
timeFrame: One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine
measure: Number of Subjects With Unsolicited Adverse Events
timeFrame: Within the 31-day (Days 0-30) post-primary vaccination period, across doses
measure: Number of Subjects With Unsolicited Adverse Events
timeFrame: Within the 31-day (Days 0-30) post booster vaccination period
measure: Number of Subjects With Serious Adverse Events
timeFrame: During the primary vaccination period
measure: Number of Subjects With Serious Adverse Events
timeFrame: During the booster vaccination period
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Morvik
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Dolny Kubin
country: Slovakia
facility: GSK Investigational Site
city: Ruzomberok
country: Slovakia
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
citation: Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
citation: Schuerman L et al. Prevention of invasive pneumococcal disease and meningitis with PHiD-CV when used according to a 2+1 schedule. Abstract presented at the Meningitis Research Foundation Conference (MRFC). London, UK, 11-12 November 2009.
citation: Silfverdal SA, Hogh B, Bergsaker MR, Skerlikova H, Lommel P, Borys D, Schuerman L. Immunogenicity of a 2-dose priming and booster vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine. Pediatr Infect Dis J. 2009 Oct;28(10):e276-82. doi: 10.1097/INF.0b013e3181b48ca3.