Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.

NCT ID: NCT00609492

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-03
• Study Completion Date: 2009-03-30

Brief Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. 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 =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Streptococcal; Streptococcus Pneumoniae Vaccines

Study Design

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

Study Groups

Preterm I Group

Children born after a gestation period of 27-30 weeks

Group Type: EXPERIMENTAL

GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Infanrix™-IPV/Hib

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Preterm II Group

Children born after a gestation period of 31-36 weeks

Group Type: EXPERIMENTAL

GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Infanrix™-IPV/Hib

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Full term Group

Children born after a gestation period of more than 36 weeks

Group Type: ACTIVE_COMPARATOR

GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Infanrix™-IPV/Hib

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection

Interventions

GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)

Single dose, intramuscular injection

Intervention Type: BIOLOGICAL

Infanrix™-IPV/Hib

Single dose, intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
• A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.
• Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737
• History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of seizures or progressive neurological disease
• Acute disease at the time of enrolment.
• Febrile illness defined as oral, axillary or tympanic temperature < 37.5°C / rectal temperature < 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.

• Minimum Eligible Age: 16 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

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Ioannina, , Greece

GSK Investigational Site

Thessaloniki, , Greece

GSK Investigational Site

Burgos, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Móstoles/Madrid, , Spain

Countries

Greece; Spain

References

Omenaca F, Merino JM, Tejedor JC, Constantopoulos A, Papaevangelou V, Kafetzis D, Tsirka A, Athanassiadou F, Anagnostakou M, Francois N, Borys D, Schuerman L. Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 2011 Aug;128(2):e290-8. doi: 10.1542/peds.2010-1184. Epub 2011 Jul 4.

Reference Type: BACKGROUND

PMID: 21727108 (View on PubMed)

Omenaca F et al. Booster vaccination of preterm-born children with 10-valent pneumococcal non-typeable haemophilus influenzae protein D-conjugate vaccine (PHiD-CV): antibody responses and safety. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 18-22 November 2009.

Reference Type: BACKGROUND

Omenaca F et al. Immunogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) following primary and booster vaccination in preterm-born children. Abstract presented at Excellence In Paediatrics. Florence, Italy, 3-6 December 2009.

Reference Type: BACKGROUND

Study Documents

Document Type: Annotated Case Report Form

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: Informed Consent Form

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: Individual Participant Data Set

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

2007-000596-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109621

Identifier Type: -

Identifier Source: org_study_id