Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants

NCT ID: NCT00390910

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-01
• Study Completion Date: 2008-05-02

Brief Summary

This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.

This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)

Detailed Description

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

Conditions

Infections, Streptococcal

Keywords

Pneumococcal vaccine; Preterm; Safety; Pneumococcal disease; Immunogenicity

Study Design

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

Study Groups

Synflorix™ + Infanrix™ hexa Group I

Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Infanrix hexa

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Synflorix™ + Infanrix™ hexa Group II

Mild pretem infants born after a gestation period of 31-36 weeks (217-258 days)

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Infanrix hexa

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Synflorix™ + Infanrix™ hexa Group III

Infants born after a gestation period of more than 36 weeks (more than 258 days)

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Infanrix hexa

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Infanrix hexa

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa-HBV-IPV/Hib

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
• A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Born after a gestation period of >27 weeks (at least 189 days).
• If full term born, healthy subjects as established by medical history and clinical examination before entering into the study
• If premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery).

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 study vaccines, or planned use during the study period
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit 6.
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
• History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past).
• Acute disease at the time of enrolment.
• 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 one month preceding the first dose of study vaccines or planned administration during the active phase of the study.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 16 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

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Ioannina, , Greece

GSK Investigational Site

Rio/Patras, , 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)

Omeneca F et al. Vaccination of pre-term infants with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHID-CV). Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Reference Type: BACKGROUND

Omeneca 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: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

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

107737

Identifier Type: -

Identifier Source: org_study_id