Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose

NCT ID: NCT01119625

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-12
• Study Completion Date: 2011-02-17

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.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group

children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Infanrix-IPV/Hib

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group

children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

Group Type: ACTIVE_COMPARATOR

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Infanrix-IPV/Hib

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Interventions

Pneumococcal vaccine GSK1024850A

Intramuscular injection, one dose

Intervention Type: BIOLOGICAL

Infanrix-IPV/Hib

Intramuscular injection, one dose

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 21 Months
• 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

Singapore, , Singapore

GSK Investigational Site

Singapore, , Singapore

GSK Investigational Site

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 25278086 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

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

View Document

Document Type: Informed Consent Form

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

Document Type: Individual Participant Data Set

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

View Document

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Related Links

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Other Identifiers

113266

Identifier Type: -

Identifier Source: org_study_id