Clinical trial NCT00808444: Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
Official title: Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine
Immunogenicity
Primary vaccination
Safety
Pneumococcal disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 466
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
* Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
* Free of any known or suspected 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 product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
* History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurological disorders or seizures.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.

Primary outcomes:
measure: Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
timeFrame: One month after primary immunization (month 4)
measure: Concentration of Antibody Against Protein D (PD)
timeFrame: One month after primary immunization (month 4)
Secondary outcomes:
measure: Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
timeFrame: One month after primary immunization (month 4)
measure: Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL
timeFrame: One month after primary immunization (month 4)
measure: Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
timeFrame: One month after primary immunization (month 4)
measure: Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
timeFrame: One month after primary immunization (month 4)
measure: Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes
timeFrame: One month after primary immunization (month 4)
measure: Poliovirus Types 1, 2 and 3 Titers
timeFrame: One month after primary immunization (month 4)
measure: Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)
timeFrame: One month after primary immunization (month 4)
measure: Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).
timeFrame: One month after primary immunization (month 4)
measure: Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)
timeFrame: 3 months after primary immunization (month 4)
measure: Occurrence of Serious Adverse Events
timeFrame: Following vaccination and throughout the entire study period (Month 0 to Month 4)
measure: Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
timeFrame: One month after primary immunization (month 4)
measure: Number of Subjects With Solicited Local and General Symptoms.
timeFrame: Within 4 days (day 0-3) after vaccination
measure: Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
timeFrame: One month after primary immunization (month 4)
measure: Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
timeFrame: One month after primary immunization (month 4)
measure: Occurrence of Unsolicited Adverse Events
timeFrame: Within 31 days (day 0-30) after vaccination
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Seremban, Negeri Sembilan
country: Malaysia
facility: GSK Investigational Site
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.