Clinical trial NCT00950833: Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Official title: Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Catch-up vaccination
Pneumococcal vaccine
Immune memory
Nasopharyngeal carriage
Immunogenicity
Pneumococcal disease
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 466
Sex: ALL
Minimum age (years): 31
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

This protocol posting deals with objectives \& outcome measures of the extension phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).

Detailed description: This protocol posting has been updated according to Protocol Amendment 1, July 2009

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
* Subjects who previously participated in study NCT00496015
* For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
* For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
* 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.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* History of seizures or progressive neurological disease.
* Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
* Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
* Administration of any pneumococcal vaccine since the end of study NCT00496015.

Primary outcomes:
measure: Antibody Concentrations Against Vaccine Pneumococcal Serotypes
timeFrame: At 7-10 days after the first vaccine dose
Secondary outcomes:
measure: Antibody Concentrations Against Vaccine Pneumococcal Serotypes
timeFrame: Prior to the first study vaccine dose (At Day 0)
measure: Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
timeFrame: Prior to (Day 0) and 7-10 days after the first vaccine dose
measure: Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A
timeFrame: Prior to (Day 0) and 7-10 days after the first vaccine dose
measure: Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
timeFrame: Prior to (Day 0) and 7-10 days after the first vaccine dose
measure: Antibody Concentrations Against Protein D (Anti-PD)
timeFrame: Prior to (Day 0) and 7-10 days after the first vaccine dose
measure: Memory B-cell Detection for Vaccine Polysaccharides (PS)
timeFrame: Prior to (Day 0) and 7-10 days after the first vaccine dose
measure: Antibody Concentrations Against Vaccine Pneumococcal Serotypes
timeFrame: At Month 12, one month after the second vaccine dose
measure: Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
timeFrame: At Month 12, one month after the second vaccine dose
measure: Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A
timeFrame: At Month 12, one month after the second vaccine dose
measure: Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
timeFrame: At Month 12, one month after the second vaccine dose
measure: Antibody Concentrations Against Protein D (Anti-PD)
timeFrame: At Month 12, one month after the second vaccine dose
measure: Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)
timeFrame: At 25-36 months post-vaccination in previous 107137 (NCT00496015) study
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (Days 0-30) after each vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 up to Month 10 or Month 12)
measure: Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
measure: Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
measure: Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
measure: Number of Nasopharyngeal Swabs With Haemophilus Influenzae
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
measure: Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
measure: Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
measure: Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
measure: Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs
timeFrame: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Jindrichuv Hradec
country: Czechia
facility: GSK Investigational Site
city: Nachod
country: Czechia
facility: GSK Investigational Site
city: Ostrava
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Praha 5
country: Czechia
facility: GSK Investigational Site
city: Praha 6
country: Czechia
facility: GSK Investigational Site
city: Praha 9
country: Czechia
facility: GSK Investigational Site
city: Znojmo
country: Czechia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Prymula R, Habib A, Francois N, Borys D, Schuerman L. Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine. 2013 Apr 12;31(16):2080-8. doi: 10.1016/j.vaccine.2013.01.044. Epub 2013 Feb 5.
citation: Prymula R et al. Immune memory 2-3 years after vaccination with pneumococcal non-typeable Heamophilus influenzae protein-D conjugate vaccine (PHiD-CV), with or without prophylactic paracetamol. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.
citation: Prymula R et al. Long-term effect of 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) on nasopharyngeal bacterial carriage in Czech children. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.
citation: Silfverdal SA et al. Immunogenicity and reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) during the fourth year of life. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.