Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™

NCT ID: NCT00680914

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-10
• Study Completion Date: 2009-05-08

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.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Synflorix Group

Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A (Synflorix)

Intervention Type: BIOLOGICAL

3 doses administered intramuscularly.

GSK Biologicals' Hiberix™

Intervention Type: BIOLOGICAL

3 doses administered intramuscularly.

Prevenar Group

Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.

Group Type: ACTIVE_COMPARATOR

Prevenar

Intervention Type: BIOLOGICAL

3 doses administered intramuscularly.

GSK Biologicals' Hiberix™

Intervention Type: BIOLOGICAL

3 doses administered intramuscularly.

Interventions

Pneumococcal vaccine GSK1024850A (Synflorix)

3 doses administered intramuscularly.

Intervention Type: BIOLOGICAL

Prevenar

3 doses administered intramuscularly.

Intervention Type: BIOLOGICAL

GSK Biologicals' Hiberix™

3 doses administered intramuscularly.

Intervention Type: BIOLOGICAL

Other Intervention Names

Hib

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ansan, , South Korea

GSK Investigational Site

Bucheon-si, , South Korea

GSK Investigational Site

Daejeon, , South Korea

GSK Investigational Site

Gyeongnam, , South Korea

GSK Investigational Site

Iksan, , South Korea

GSK Investigational Site

Jeju City, , South Korea

GSK Investigational Site

Jeonju Jeonbuk, , South Korea

GSK Investigational Site

Pusan, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon, , South Korea

GSK Investigational Site

Wonju-si Kangwon-do, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 21817957 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 21994351 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

110808

Identifier Type: -

Identifier Source: org_study_id