Clinical trial NCT00911144: Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
Official title: Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Safety
Pneumococcal vaccine
Immunogenicity
Pneumococcal disease
Booster vaccination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.


Eligibility criteria: Inclusion Criteria:

* A male or female between, and including, 12-18 months of age at the time of booster vaccination.
* Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
* Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
* Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
* 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 (drug or vaccine) within 30 days preceding the 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 (pharmaceutical product or device).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
* Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
* Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of reactions 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.
* Tympanic or axillary/ oral temperature \>= 37.5°C or rectal temperature \>= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
* Acute disease at the time of enrolment.

Primary outcomes:
measure: Number of Subjects Reporting Grade 3 Adverse Events
timeFrame: Within 31 days (Day 0 - Day 30) after booster vaccination.
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Symptoms
timeFrame: Within 4 days (Days 0 to 3) after booster vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events
timeFrame: Within 31 days (Days 0 to 30) after booster vaccination
measure: Number of Subjects Reporting Serious Adverse Events
timeFrame: After booster vaccination up to study end (Month 0 to Month 1)
measure: Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
timeFrame: One month after booster vaccination (Month 1)
measure: Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
timeFrame: One month after booster vaccination (Month 1)
measure: Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
timeFrame: One month after booster vaccination (Month 1)
measure: Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
timeFrame: One month after booster vaccination (Month 1)
measure: Concentration of Antibodies Against Protein D (PD)
timeFrame: One month after booster vaccination (Month 1)
measure: Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
timeFrame: One month after booster vaccination (Month 1)
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon-Si, GyeongGi-do,
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: GyeongSangNam-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Iksan
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeju City
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: Suwon City, Gyeonggi-do
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 JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
citation: Kim KH et al. Immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.