Clinical trial NCT01119625: Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
Official title: Evaluation of Immunological Persistence Following 3-dose Priming With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine in Study NCT00808444 and Safety and Immunogenicity Following a Booster Dose of the Same Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: safety
Streptococcus pneumoniae
immunogenicity
Pneumococcal conjugate vaccine
Haemophilus influenzae
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.

The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
* Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
* Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
* Written informed consent obtained from the parents/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
* 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.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* A family history of congenital or hereditary immunodeficiency.
* Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
* Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
* Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
* Fever at the time of vaccination.

  * Fever is defined as rectal temperature \>= 38.0°C or tympanic/axillary/ oral temperature \>= 37.5°C.
* Acute disease at the time of enrolment.

  * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Child in care.

Primary outcomes:
measure: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
timeFrame: Before booster vaccination at Month 0
measure: Concentrations of Antibodies Against Protein D (PD).
timeFrame: Before booster vaccination at Month 0
Secondary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
timeFrame: Within 4 days (Days 0-3) after booster vaccination.
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
timeFrame: Within 4 days (Days 0-3) after booster vaccination.
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs).
timeFrame: Within 31 days (Days 0-30) after booster vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAEs).
timeFrame: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1
measure: Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
timeFrame: Before booster vaccination at Month 0
measure: Concentrations of Antibodies Against Diphtheria and Tetanus.
timeFrame: Before booster vaccination at Month 0
measure: Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
timeFrame: Before booster vaccination at Month 0
measure: Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
timeFrame: Before booster vaccination at Month 0
measure: Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
timeFrame: Before booster vaccination at Month 0
measure: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Concentrations of Antibodies Against Protein D (PD).
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Concentrations of Antibodies Against Diphtheria and Tetanus.
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
measure: Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
timeFrame: Before and one month after booster vaccination (at Month 0 and Month 1)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.