Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria

NCT ID: NCT01153893

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-04
• Study Completion Date: 2011-02-16

Brief Summary

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Nigerian subjects previously enrolled in the primary vaccination study NCT00678301.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).

Conditions

Infections, Streptococcal

Study Design

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

Study Groups

Synflorix/Infanrix primed Group

Subjects previously primed with the Synflorix™ vaccine in the primary study 110521 (NCT00678301) received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 or 2 doses

InfanrixTM

Intervention Type: BIOLOGICAL

Intramuscular injection, 1dose

Synflorix/Infanrix unprimed Group

Unprimed subjects from the primary study 110521 (NCT00678301), not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 or 2 doses

InfanrixTM

Intervention Type: BIOLOGICAL

Intramuscular injection, 1dose

Interventions

Pneumococcal vaccine GSK1024850A

Intramuscular injection, 1 or 2 doses

Intervention Type: BIOLOGICAL

InfanrixTM

Intramuscular injection, 1dose

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
• A male or female, between and including 15-21 months of age at the time of visit 1.
• For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
• Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(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.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
• 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.
• Administration of any pneumococcal vaccine since the end of study NCT00678301.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
• Major congenital defects or serious chronic illness.
• History of any progressive neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
• Child in care.

• Minimum Eligible Age: 15 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

Ikeja / Lagos, , Nigeria

Countries

Nigeria

References

Odusanya OO, Kuyinu YA, Kehinde OA, Shafi F, Francois N, Yarzabal JP, Dobbelaere K, Ruggeberg JU, Borys D, Schuerman L. Safety and immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: Booster dose and 2-dose catch-up regimens in the second year of life. Hum Vaccin Immunother. 2014;10(3):757-66. doi: 10.4161/hv.27276. Epub 2013 Dec 4.

Reference Type: DERIVED

PMID: 24356787 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

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: Dataset Specification

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: Study Protocol

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

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

113199

Identifier Type: -

Identifier Source: org_study_id