Booster and Catch-up Vaccination With Vaccine GSK1024850A

NCT ID: NCT01030822

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-02
• Study Completion Date: 2011-08-19

Brief Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710.

This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.

The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.

Detailed Description

The study is randomized for primed subjects and non-randomized for unprimed subjects.

The protocol posting has been updated according to the amendment of the protocol dated 16 April 2010. The age range at the time of randomization of subjects primed in study NCT00814710 and the age range for booster vaccination of one of the groups has been extended.

Conditions

Infections, Streptococcal

Study Design

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

Study Groups

Group A

Subjects previously primed with pneumococcal vaccine GSK1024850A in the first year of life and receiving a booster dose of GSK1024850A at 9-18 months of age.

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, administered as a single dose

Group B

Subjects previously primed with pneumococcal vaccine GSK1024850A in the first year of life and receiving a booster dose of GSK1024850A at 15-18 months of age.

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, administered as a single dose

Group C

Unprimed subjects receiving a catch-up vaccination (2+1 schedule) in the second year of life.

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

Pneumococcal vaccine GSK1024850A

Intramuscular injection, administered as a single dose

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK1024850A

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
• Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

For primed subjects:

• Completion of the full vaccination course in study NCT00814710.
• 9-18 months of age at the time of randomization.
• Group A: 9-18 months of age at the time of booster vaccination.
• Group B: 15-18 months of age at the time of booster vaccination.

For unprimed subjects (Group C):

• Enrolled in study NCT00814710.
• 12-18 months of age at the time of first vaccination.

Exclusion Criteria

• Use of any investigational or non-registered product 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.
• Chronic administration 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 vaccine since the end of study NCT00814710.
• 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 vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 18 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

Kolkata, , India

GSK Investigational Site

Ludhiana, , India

GSK Investigational Site

Pune, , India

GSK Investigational Site

Vellore, , India

Countries

India

References

Lalwani S. et al. Impact of age on booster responses to 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in children in India. Abstract presented at the 6th Asian Congress of Pediatric Infectious Diseases (ACPID), Colombo, Sri Lanka, 28 Nov - 01 Dec 2012.

Reference Type: BACKGROUND

Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.

Reference Type: DERIVED

PMID: 25008901 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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: Clinical Study Report

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: Study Protocol

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

Document Type: Annotated Case Report Form

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

112909

Identifier Type: -

Identifier Source: org_study_id