Clinical trial NCT00680914: Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
Official title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Streptococcus pneumoniae
pneumococcal conjugate vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 503
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 purposes of this study are:

To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life.

To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.

Detailed description: Vaccination course at 2, 4, 6 months of age.

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 should be enrolled in the study.
* Written and signed 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 inclusive, with a birth weight of at least 2.5 kilogram.

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, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
* 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 (Hepatitis B immunoglobulins at birth are allowed).
* Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
* History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b 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. Study entry should be delayed until the illness has improved.

Primary outcomes:
measure: Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
timeFrame: One month after administration of 3rd dose of the pneumococcal conjugate vaccine
Secondary outcomes:
measure: Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Anti-PD Antibody Concentration
timeFrame: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Number of Subjects With Seroprotection Status Against PRP
timeFrame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: Within 4 days after each vaccination
measure: Number of Subjects With Solicited General Symptoms
timeFrame: Within 4 days after each vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events
timeFrame: Within 31 days after each vaccination
measure: Number of Subjects With Serious Adverse Events (SAE)
timeFrame: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon-si,
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeongnam
country: Korea, Republic of
facility: GSK Investigational Site
city: Iksan
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeju
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju Jeonbuk
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon City
country: Korea, Republic of
facility: GSK Investigational Site
city: Wonju-si Kangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.
citation: Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
citation: Kim CH et al. Immunogenicity of a 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and co-administered vaccines following primary vaccination in Asian infants. Abstract presented at the 5th Asian Congress of Pediatric Infectious Diseases (ACPID). Taipei, Taiwan, 23-26 September 2010.
citation: Kim JS et al. Safety and reactogenicity of primary vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
citation: Kim KH et al. Immunogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
citation: Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12.
citation: Schuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal 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. OPA assay is more reliable predictor of vaccine effectiveness against invasive pneumococcal disease (IPD) than ELISA antibody measurements. 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 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.